| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 001 10 23 000 | ICU Medical, Inc | Plum 360 Infusion System | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00607-1 |
| mdprc 004 09 23 000 | Shenzhen Mindray Bio-medical Electronics Co., Ltd, | SV600/800 Mindray Ventilator | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00730-1 |
| mdprc 002 09 23 000 | Siemens Medical Solutions | ACUSON Redwood 2.0 ultrasound systems - 18L6 transducer | TGA |
| mdprc 039 08 23 000 | Ortho-Clinical Diagnostics | ORTHO Sera Anti-Lea Murine Monoclonal IgM. | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00742-1 |
| mdprc 018 08 23 000 | Instrumentation Laboratory SpA, a Werfen Company | ACL TOP | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00591-1 |
| mdprc 011 08 23 000 | Draeger Medical Systems Inc | Babyleo TN500 IncuWarmer | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00352-1 |
| mdprc 016 10 22 001 | Siemens Healthcare Diagnostics GmbH | Atellica CH 930 Analyzer, Lithium and Lithium_2 | BfArM |
| mdprc 002 08 23 000 | Bio-Rad Laboratories Inc | Liquichek Pediatric Control. | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00649-1 |
| mdprc 029 07 23 000 | Ventana Medical Systems | UltraView Universal AP Red Detection Kit | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00561-1 |
| mdprc 033 03 22 001 | Atrium Medical Corporation | Atrium Advanta V12 Covered Stent System | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00419-1 |
| mdprc 039 06 23 000 | Johnson & Johnson Surgical Vision, Inc. | VERITAS Advanced Infusion and Fluidics Packs | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00519-1 |
| mdprc 019 06 23 001 | Shimadzu Corporation.. | Shimadzu X-Ray system - X-Ray tube support, ceiling mounted CH-200/CH-200M | TGA, NCMDR |
| mdprc 034 06 23 000 | GS Elektromedizinische Geräte G. Stemple GmbH | Corpuls3 Software | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00309-1 |
| mdprc 030 05 23 000 | Biocartis NV. | BRAF Mutation Assay | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00328-1 |
| mdprc 009 03 23 000 | Sebia | CAPILLARYS 3 TERA, CAPILLARYS 3 OCTA | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01399-1 |
| mdprc 029 11 22 001 | SIEMENS | Syngo.via with VB20, VB30, VB40, VB60 and VB70 software | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00043-1 |
| mdprc 006 01 23 000 | Agilent Technologies, Inc. | Dako CoverStainer CS10030 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01581-1 |
| mdprc 044 12 22 000 | AGFA Corp. | Enterprise Imaging XERO Viewer | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01511-1 |
| mdprc 040 12 22 000 | Philips Healthcare | Philips 12-Lead Chest Lead-set | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01345-1 |
| mdprc 013 12 22 000 | DiaMed GmbH. | ID-DiaPanel | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01445-1 |
| mdprc 008 12 22 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products Intact PTH Reagent Pack | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01472-1 |
| mdprc 007 12 22 000 | Olympus | Endoeye Flex 3d Deflectable Videoscope, LTF-190-10-3D | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01441-1 |
| mdprc 006 12 22 000 | SIEMENS | Sensis, Sensis Vibe Hemo, Sensis Vibe Combo | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01459-1 |
| mdprc 026 10 22 000 | FUJIFILM Medical Systems | Synapse PACS Version 5.x | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01311-1 |
| mdprc 020 10 22 001 | Phadia Ltd | ImmunoCAP Allergen f76. | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01308-1 |
| mdprc 014 10 22 000 | Cepheid | Xpert EV | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01236-1 |
| mdprc 005 10 22 000 | ZOLL Medical Corp | Li-ion Battery Model 100 (AutoPulse brand) used with ZOLL’s AutoPulse Resuscitation System | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01270-1 |
| mdprc 007 03 22 001 | SIEMENS | ARTIS icono biplane, ARTIS icono floor, and ARTIS pheno Systems with syngo Application Software | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=194235 |
| mdprc 009 09 22 000 | Siemens Healthcare Diagnostics GmbH | Dimension Magnesium (MG) Flex reagent cartridge. | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01197-1 |
| mdprc 008 09 22 000 | bioMerieux Inc | VIDAS 3 system | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01198-1 |
| mdprc 006 09 22 000 | SIEMENS | Artis system | TGA |
| mdprc 004 08 22 000 | SIEMENS | AXIOM Sensis XP, Sensis / Sensis Lite or Sensis Vibe Combo | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00969-1 |
| mdprc 032 07 22 000 | Smiths Medical International Limited | Level 1 Fast Fluid Flow Fluid Warmers | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00850-1 |
| mdprc 026 07 22 000 | Tandem Diabetes Care, Inc | t:slim X2 Insulin Pump | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00627-1 |
| mdprc 008 07 22 000 | 3Shape Medical A/S. | 3Shape Implant Studio software | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00835-1 |
| mdprc 007 07 22 000 | DiaMed GmbH. | ID-DiaPanel Plus 6 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00844-1 |
| mdprc 006 07 22 000 | Sysmex Corporation Japan | SP-50 slidemaker-stainer | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00724-1 |
| mdprc 029 06 22 000 | Randox Laboratories Ltd. | Calibration Serum Level 3 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00817-1 |
| mdprc 018 06 22 000 | Draeger Medical Systems Inc | BiliLux - Spring Arm | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00722-1 |
| mdprc 011 06 22 000 | SIEMENS | Ysio systems with VC10 software | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00228-1 |
| mdprc 009 06 22 000 | Radiometer Medical | ABL800 Basic and ABL8XX FLEX | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00710-1 |
| mdprc 008 06 22 000 | Acutronic Medical Systems AG. | fabian HFOi ventilators with software version older than 5.2.1 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00569-1 |
| mdprc 014 12 20 001 | Siemens Healthcare Diagnostics GmbH | ADVIA 1800 Chemistry System, ADVIA 2400 Chemistry System, ADVIA Chemistry XPT and Atellica CH 930 Analyzer - Gamma-Glutamyl Transferase | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01244-1 |
| mdprc 012 04 22 000 | bioMerieux Inc | VITEK 2 GP ID Test Kit | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00418-1 |
| mdprc 053 03 22 000 | Philips Healthcare | Philips CombiDiagnost R90 and ProxiDiagnost N90 Systems with software version 1.1.1 or higher | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00344-1 |
| mdprc 051 03 22 000 | Siemens Healthcare Diagnostics | Atellica UAS 800 Urine Sediment Analyser and Atellica 1500 Automated Urinalysis System | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00411-1 |
| mdprc 035 03 22 000 | VOLCANO CORPORATION | IntraSight IVUS Systems | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00490-1 |
| mdprc 032 03 22 000 | Siemens Healthcare Diagnostics Product | Human Chorionic Gonadotropin (HCG) IVD | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00341-1 |
| mdprc 016 03 22 000 | Siemens Healthcare Diagnostics GmbH | Various Assays on Atellica CH 930 Analyzers | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RChttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00302-1 |
| mdprc 027 02 22 000 | Pulsion Medical Systems | PiCCO Monitoring Kit, 150cm line 5/pkg | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00264-1 |
| mdprc 022 02 22 000 | Instrumentation Laboratory SpA | HemosIL AcuStar ADAMTS13 Activity | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00266-1 |
| mdprc 018 01 22 001 | Philips Healthcare | Philips Fetal Spiral Electrode | TGA, NCMDR |
| mdprc 009 01 22 000 | Shimadzu Corporation | Shimadzu Sonialvision G4 and Sonialvision Safire 17 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02429-1 |
| mdprc 007 01 22 000 | Bio Rad. | Trimethoprim Sulfametoxazole 1.25-23.75 µg disk | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02418-1 |
| mdprc 003 01 22 000 | Phadia Ltd | ImmunoCAP Total IgE, ImmunoCAP Specific IgE and ViewAllergy | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02361-1 |
| mdprc 022 12 21 000 | Draeger Medical Systems Inc | Perseus A500 Anesthesia workstation ceiling mounted version | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02378-1 |
| mdprc 021 12 21 000 | Draeger Medical Systems Inc | Babyleo TN500 IncuWarmer | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02270-1 |
| mdprc 033 11 21 001 | AMO Manufacturing USA, LLC | CATALYS Precision Laser System and iDESIGN Refractive Studio | TGA, Swissmedic |
| mdprc 001 12 21 000 | Olympus | TJF-Q180V duodenoscopes | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02057-1 |
| mdprc 018 11 21 000 | Bio Rad. | BioPlex 2200 APLS IgM and BioPlex 2200 APLS IgA | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02166-1 |
| mdprc 009 11 21 000 | The Binding Site | Freelite Human Lambda Free Kit (for use on the SPAPLUS) | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02087-1 |
| mdprc 022 10 21 000 | Beckman Coulter | DxC AU Glucose Reagent | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02053-1 |
| mdprc 025 09 21 000 | Beckman Coulter | Inorganic Phosphorus | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01795-1 |
| mdprc 010 09 21 000 | Bio Rad. | VIROTROL ToRCH-M | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01657-1 |
| mdprc 039 08 21 000 | Draeger Medical Systems Inc | Babylog VN500, Evita V300 and Evita V500 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01771-1 |
| mdprc 027 08 21 000 | LiNA Medical | Lina Xcise Laparoscopic Morcellator. | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2021-RN-01568-1 |
| mdprc 017 05 20 001 | Beckman Coulter | Access hsTnI Reagent | NCMDR |
| mdprc 018 08 21 000 | Olympus | CV-1500 Processor, CF-EZ1500DI Colonovideoscope, CF-EZ1500DL Colonovideoscope and GIF-EZ1500 Gastrointestinal Videoscope | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01549-1 |
| mdprc 032 07 21 000 | Randox Laboratories Ltd. | Copper CU2340 R1a Buffer | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01563-1 |
| mdprc 015 07 21 000 | Gyrus ACMI | TFL-PLS SOLTIVE Premium SuperPulsed Laser System | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01424-1 |
| mdprc 036 12 20 002 | Radiometer Medical | All AQT90 FLEX analyzers with serial numbers of 393-838R0564 onwards and all E3800 spare part CPU units, 910-415 | BfArM |
| mdprc 005 07 21 001 | Sony corporation | 4K LCD Monitor | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01440-1 |
| mdprc 008 07 21 000 | Randox Laboratories Ltd. | Randox Zinc (Zn) Assay | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01451-1 |
| mdprc 002 07 21 000 | Ortho-Clinical Diagnostics | ORTHO VISION Analyzer for BioVue and ORTHO VISION Max Analyzer for BioVue | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01408-1 |
| mdprc 046 06 21 000 | OrganOX Limited | OrganOx metra Retained Unit | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01412-1 |
| mdprc 044 06 21 000 | Verathon Inc | GlideScope Go Video Monitors | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01343-1 |
| mdprc 040 06 21 000 | Merit Medical Systems Inc | basixALPHA Inflation Device | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01380-1 |
| mdprc 039 06 21 000 | Beckman Coulter | Access CEA Reagent | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01329-1 |
| mdprc 032 06 21 000 | Siemens Healthcare Diagnostics GmbH | Atellica CH 930 Analyser, Atellica IM 1300 Analyser and Atellica IM 1600 Analyser | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01278-1 |
| mdprc 011 06 21 000 | Siemens Healthcare Diagnostics | Atellica UAS 800 Urine Sediment Analyser and Atellica 1500 Automated Urinalysis System | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01232-1 |
| mdprc 016 05 21 000 | Beckman Coulter | Access Sensitive Estradiol | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01015-1 |
| mdprc 009 05 21 000 | Beckman Coulter | Access 25(OH) Vitamin D Total for use in Access 2 and DxI Immunoassay systems | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00958-1 |
| mdprc 008 05 21 000 | Beckman Coulter | Access Sensitive Estradiol | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00961-1 |
| mdprc 001 05 21 000 | Welch Allyn, Inc | GS777 Wall Transformer (all models) and ProBP 3400 (handheld, desk mount, wall mount models) | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01007-1 |
| mdprc 028 04 21 000 | SIEMENS | syngo.via software VB30 version | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00973-1 |
| mdprc 027 04 21 000 | Draeger Medical Systems Inc | Dräger Ventilators | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00964-1 |
| mdprc 019 04 21 000 | Dentsply Sirona, Inc | The Intego/Intego Pro | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00985-1 |
| mdprc 044 03 21 000 | Beckman Coulter | IMMAGE Immunochemistry Systems | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00705-1 |
| mdprc 039 03 21 000 | Medtronic SA | Enhanced Enlite Sensor (MMT-7008) and Guardian Sensor 3 (MMT-7020) | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00677-1 |
| mdprc 038 03 21 000 | Medtronic SA | VenaSeal Closure System | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00788-1 |
| mdprc 037 03 21 000 | Siemens Healthcare Diagnostics Product | Atellica NEPH 630 System 1.1 and BN ProSpec System 1.4.3 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00646-1 |
| mdprc 005 02 21 002 | bioMerieux Inc | VIDAS CVM IgM. | TGA, Swissmedic |
| mdprc 029 03 21 000 | Merit Medical Systems Inc | Merit Medical Surgical Procedure Kits containing BD Syringes and Needles | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00425-1 |
| mdprc 021 03 21 000 | Medtronic SA | Heartware HVAD System | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00572-1 |
| mdprc 007 06 20 001 | Siemens Healthcare Diagnostics GmbH | Atellica IM 1300 Analyser / Atellica IM 1600 Analyser | TGA, Swissmedic |
| mdprc 020 02 21 000 | SIEMENS | syngo.via software update VB20A | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00360-1 |
| mdprc 018 02 21 000 | Siemens Healthcare Diagnostics GmbH | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex Reagent Cartridge | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00323-1 |
| mdprc 015 02 21 000 | SIEMENS | SOMATOM CT scanners running on syngo CT VB20A_SP3 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00352-1 |
| mdprc 002 02 21 000 | Siemens Medical Solutions | Syngo.via all systems with software version VB40A or VB40B | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2021-RN-00053-1 |
| mdprc 001 02 21 000 | CERNER CORPORATION | FetaLink | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00187-1 |
| mdprc 023 01 21 000 | Siemens Healthcare Diagnostics Inc | Atellica IM and ADVIA Centaur XP/XPT Free Prostate-Specific Antigen (fPSA) | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2021-RN-00107-1 |
| mdprc 022 01 21 000 | Boston Scientific | Single-Use Polypectomy Snares: Captivator, Captivator II, Captiflex, and Sensation | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2021-RN-00154-1 |
| mdprc 004 02 20 003 | Siemens Healthcare Diagnostics Inc | Atellica CH Reaction Cuvette Segment | Swissmedic |
| mdprc 005 01 21 000 | Becton Dickinson & Co. (BD) | Alaris GP Volumetric Pump with Plus software | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01389-1 |
| mdprc 051 05 19 001 | Medtronic | Medtronic HeartWare Monitor AC Adapter | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01420-1 |
| mdprc 035 12 20 000 | Terumo BCT Inc | Spectra Optia Apheresis System | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01359-1 |
| mdprc 010 11 20 000 | Philips Healthcare | Philips V60 Ventilator | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01040-1 |
| mdprc 009 11 20 000 | Siemens Healthcare Diagnostics GmbH | Atellica IM 1300 and 1600 Analyser | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01067-1 |
| mdprc 002 11 20 000 | Ortho-Clinical Diagnostics | VITROS System Software Version 3.6. | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00970-1 |
| mdprc 018 10 20 000 | SLE | SLE4000 & SLE5000 – Control Monitor Boards | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00916-1 |
| mdprc 014 10 20 000 | GS Elektromedizinische Geräte G. Stemple GmbH | Corpuls3 devices | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00812-1 |
| mdprc 003 10 20 000 | W.L. Gore & Associates Inc. | GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00847-1 |
| mdprc 037 09 20 000 | Kowa Company, Ltd. | Kowa VK-2s Kowa Retinal Camera | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00846-1 |
| mdprc 035 09 20 000 | SIEMENS | SOMATOM Definition AS (Family), Definition Edge & Definition Flash | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00836-1 |
| mdprc 016 05 20 001 | Beckman Coulter | IMMAGE Immunochemistry Systems | NCMDR |
| mdprc 018 09 20 000 | Dako Denmark A/S | Dako Autostainer | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00790-1 |
| mdprc 017 09 20 000 | Inpeco S.A . | Aptio Automation | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00778-1 |
| mdprc 005 09 20 000 | SIEMENS | syngo.plaza VB30A, VB30B and VB30C | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00726-1 |
| mdprc 018 01 20 001 | Stryker | LIFEPAK 15 Monitor/Defibrillator | TGA, Swissmedic |
| mdprc 012 08 20 000 | Philips Healthcare | Philips 3.7V Rechargeable Li-Polymer Battery for Expression MR400 MRI Patient Monitoring System Modules | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00565-1 |
| mdprc 004 08 20 000 | WASSENBURG Medical B.V. | Wassenburg Dryer320 | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00248-1 |
| mdprc 017 07 20 000 | FUJIFILM Medical Systems | FUJIFILM Synapse PACS Version 5.5.x and 5.7.x | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00544-1 |
| mdprc 041 06 20 000 | Philips Healthcare | Philips M3015A Microstream CO2 Extension | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00462-1 |
| mdprc 040 06 20 000 | Philips Healthcare | Philips 866173 IntelliVue G7m Anaesthesia Gas Modules | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00516-1 |
| mdprc 039 06 20 000 | Johnson & Johnson Medical GmbH | Virgin Silk Suture | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00511-1 |
| mdprc 015 12 19 002 | ResMed Limited. | Stellar 100 and 150 Portable Ventilators | NCMDR |
| mdprc 022 06 20 000 | Siemens Healthcare Diagnostics Product | IMMULITE 2000 Immunoassay System and IMMULITE 2000 XPi Immunoassay System Waste Bottle Flexible Tube | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00448-1 |
| mdprc 019 06 20 000 | Beckman Coulter | Access Sensitive Estradiol Calibrators | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00382-1 |
| mdprc 049 11 19 002 | Tornier Inc | Aequalis Ascend Flex Stem Implants | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01666-1 |
| mdprc 015 05 20 000 | Philips Healthcare | Brilliance iCT, Brilliance iCT SP system, and IQon Spectral CT | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00376-1 |
| mdprc 009 05 20 000 | Beckman Coulter | ß-2 Microglobulin | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00368-1 |
| mdprc 090 05 19 001 | Beckman Coulter UK Ltd | Power Express Sample Processing System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=179661 |
| mdprc 015 04 20 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Chemistry Systems 1800/2400/XPT & Atellica CH 930 Analyser | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00308-1 |
| mdprc 012 04 20 000 | Medtronic | CareLink 2090 Programmer & Encore 29901 Programmer | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2020-RN-00333-1 |
| mdprc 087 09 18 001 | Baxter Healthcare | AK 98 Hemodialysis Devices | NCMDR |
| mdprc 029 03 20 000 | Siemens Healthcare Diagnostics GmbH | Atellica CH 930 Analyser | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00218-1 |
| mdprc 019 03 20 000 | Establishment Labs S.A. | Motiva Sterile Silicone Breast Implants | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00078-1 |
| mdprc 017 03 20 000 | POLYTECH Health & Aesthetic GmbH | POLYTECH Breast Implants | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00187-1 |
| mdprc 015 03 20 000 | Siemens Healthcare Diagnostics GmbH | Dimension Total Bilirubin (TBI) Flex reagent cartridge | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00178-1 |
| mdprc 003 03 20 000 | Siemens Healthcare Diagnostics GmbH | Dimension Vista Total Bilirubin (TBIL) Flex reagent cartridge | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00177-1 |
| mdprc 002 03 20 000 | Siemens Healthcare Diagnostics GmbH | Atellica CH Direct Bilirubin (DBil_2) and Total Bilirubin (TBil_2) Assays | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00176-1 |
| mdprc 001 03 20 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Chemistry Direct Bilirubin (DBIL_2) and Total Bilirubin (TBIL_2) Assays | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00175-1 |
| mdprc 029 02 20 000 | Biocartis NV. | Biocartis BTA00606 Idylla EGFR Mutation Test | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00096-1 |
| mdprc 028 02 20 000 | Siemens Healthcare Diagnostics GmbH | Atellica CH Ethyl Alcohol (ETOH) | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00179-1 |
| mdprc 011 02 20 000 | Medtronic | McGrath X3 Disposable Laryngoscope Blades | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00139-1 |
| mdprc 013 11 19 001 | Dako Denmark A/S | Dako Autostainer Syringe Tray | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01614-1 |
| mdprc 023 01 20 000 | DNA Genotek Inc. | Oragene DNA | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01839-1 |
| mdprc 022 01 20 000 | Siemens Healthcare Diagnostics GmbH | Atellica IM Humidity Pack | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00015-1 |
| mdprc 020 01 20 000 | SIEMENS | Various Cios Systems | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00032-1 |
| mdprc 027 05 19 001 | C R Bard Inc. | EnCor Breast Biopsy Probes | NCMDR |
| mdprc 008 01 20 000 | Bedfont Scientific Limited | ‘FeNOBreath’, Factional Exhaled Nitric Oxide | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01879-1 |
| mdprc 035 11 19 001 | MAQUET Cardiopulmonary GmbH | QUADROX-iD Paediatric with BIOLINE Coating | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=178112 |
| mdprc 044 12 19 000 | Siemens Healthcare Diagnostics Inc | Atellica IM NT-proBNP (PBNP) 100 Test Kit and 500 Test Kit | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01869-1 |
| mdprc 032 12 19 000 | Linet spol. s r.o. | Eleganza 5 Beds | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01675-1 |
| mdprc 013 12 19 000 | Philips Healthcare | Xper Information Management System version 2.4.2 and 2.4.3 | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01686-1 |
| mdprc 034 11 19 000 | Nagor Limited | Textured Nagor GFX, CoGel and Impleo Mammary Implants | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01488-1 |
| mdprc 032 11 19 000 | Human Meditek CO., LTD | HMTS 142D Plasma Sterilisers | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01615-1 |
| mdprc 031 11 19 000 | Beckman Coulter | iChemVELOCITY Urine Chemistry System | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01654-1 |
| mdprc 025 11 19 001 | bioMerieux Inc | BACT/ALERT VIRTUO A & B Units | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01610-1 |
| mdprc 020 11 19 000 | Draeger Medical Systems Inc | Oxylog 3000 Transport Ventilators | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01618-1 |
| mdprc 017 11 19 000 | Siemens Healthcare Diagnostics GmbH | Atellica IM Testosterone II 100 and 500 Test Kits | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01637-1 |
| mdprc 009 11 19 000 | Stryker | InTouch Critical Care Bed | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01590-1 |
| mdprc 005 11 19 001 | Bard Peripheral Vascular Inc | Max-Core Disposable Core Biopsy Instruments | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01585-1 |
| mdprc 004 11 19 000 | POLYTECH Health & Aesthetic GmbH | Sublime Line, Microthane & 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01485-1 |
| mdprc 003 11 19 000 | Haemonetics Corp. | Haemonetics 125ml and 225ml Centrifuge Bowl | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01609-1 |
| mdprc 034 10 19 001 | Baxter Healthcare | Artiset Blood Tubing System | NCMDR |
| mdprc 001 11 19 000 | GE Healthcare | CARESCAPE Respiratory Modules | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01494-1 |
| mdprc 087 02 19 003 | Olympus | Olympus Duodenovideoscope | NCMDR |
| mdprc 038 10 19 000 | Roche Diagnostics Corp | Homocysteine | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01511-1 |
| mdprc 030 10 19 000 | Beckman Coulter | UniCel DxH Slidemaker Stainer (DxH SMS) & UniCel DxH Slidemaker Stainer II (DxH SMS II) . | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01554-1 |
| mdprc 019 10 19 000 | Baxter Healthcare | Prismaflex Control Units with software versions 7.20 and below | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01484-1 |
| mdprc 013 10 19 000 | Beckman Coulter | iChemVELOCITY Urine Chemistry Strips | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01469-1 |
| mdprc 116 09 19 001 | MAQUET Cardiopulmonary | VHK and VKMO(D) Adult/Small Adult Accessories | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01380-1 |
| mdprc 155 09 19 000 | Siemens Healthcare Diagnostics | Atellica CH 930 Analyser | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01439-1 |
| mdprc 154 09 19 000 | Randox Laboratories Ltd. | Non-Esterified Fatty Acids (NEFA) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01433-1 |
| mdprc 153 09 19 000 | Merit Medical Systems , Inc. | DTX Safedraw Kits and Meritrans DTXPlus Devices | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01432-1 |
| mdprc 152 09 19 000 | Ga Generic Assays GmbH | GA 5003, Anti-Gangliosid Dot | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01426-1 |
| mdprc 151 09 19 000 | Draeger Medical Systems Inc | IACS and Stand Alone M540 Monitor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01392-1 |
| mdprc 144 09 19 000 | Steelco SpA. | Steelco Endoscope Dryers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01092-1 |
| mdprc 143 09 19 000 | Signature Orthopaedics | ATOK Shoulder Anchor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01401-1 |
| mdprc 105 07 19 001 | Terumo BCT Inc | Spectra Optia Apheresis System | NCMDR |
| mdprc 129 09 19 000 | Zimmer, INC | ROSA Brain 3.0 Surgical Systems | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01391-1 |
| mdprc 128 09 19 000 | Philips Healthcare | Philips HeartStart FRx and HS1 OnSite Automated External Defibrillators (AEDs) | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01388-1 |
| mdprc 127 09 19 000 | GN ReSound A/S | Selected Behind-the-Ear hearing aids | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01393-1 |
| mdprc 118 09 19 000 | OriGen Biomedical | OriGen Products TissueVault O-Wrap and accessories | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01361-1 |
| mdprc 117 09 19 000 | Medifab Medical Fabrication | Shuttle Discovery with 4 Wheel Verve Stroller | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01325-1 |
| mdprc 115 09 19 000 | MAQUET Cardiopulmonary | VHK and VKMO Adult/Small Adult | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01381-1 |
| mdprc 114 09 19 000 | CODAN | Swan-Lock Needle-Free Connector | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01362-1 |
| mdprc 113 09 19 000 | Candela Corporation | GentleCool Pro Cryogen Canister | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01359-1 |
| mdprc 069 01 19 003 | Medtronic | Adapta Dual Chamber Pacemakers | NCMDR |
| mdprc 105 09 19 000 | Serres Oy | Serres Suction Bag Liner | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01323-1 |
| mdprc 104 09 19 000 | Electromedical Products International | Alpha Conducting Solution used with Alpha-Stim M & AID devices | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01314-1 |
| mdprc 103 09 19 000 | Codman & Shurtleff Inc | Cerelink ICP Monitor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01354-1 |
| mdprc 102 09 19 000 | Beckman Coulter | SYNCHRON Systems Opiate 300 ng (OP) Reagent and SYNCHRON Systems Opiate 2000 ng (OP2) Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01308-1 |
| mdprc 101 09 19 000 | Beckman Coulter | IMMAGE Total Immunoglobulin E (IgE) Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01324-1 |
| mdprc 100 09 19 000 | Beckman Coulter | SYNCHRON Systems Cannabinoid 100 ng (THC) & SYNCHRON Systems Cannabinoid 50 ng (THC5) Reagents | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01304-1 |
| mdprc 099 09 19 000 | B Braun Medical Inc | Introcan Safety IV Catheter | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01289-1 |
| mdprc 062 09 19 001 | Zimmer | Vanguard XP-CR Tibial Tray | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175837 |
| mdprc 007 08 19 001 | Cincinnati Sub-Zero Products Inc. | Norm-O-Temp Hyperthermia System, MICRO-TEMP LT System, Blanketrol II Hyper-Hypothermia System, Blanketrol III Hyper-Hypothermia System and CoolBlue Hyper-Hypothermia System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01127-1 |
| mdprc 082 09 19 000 | LabStyle Innovations Ltd | Dario Blood Glucose Tracker app | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01322-1 |
| mdprc 081 09 19 000 | ConvaTec | Various Convex Two-Piece Skin Barriers. Natura, Surfit and Combihesive Wafers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01287-1 |
| mdprc 035 09 19 001 | BD Biosciences | BD FACSLyric Flow Cytometer | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01243-1 |
| mdprc 061 09 19 000 | Prima Medical Ltd | Prima Supervac Fingerswitch Pencils with Smoke Evacuation Tubing | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01277-1 |
| mdprc 060 09 19 000 | Howmedica Osteonics Corp. | Triathlon Orthopaedic Devices | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01185-1 |
| mdprc 059 09 19 000 | Briggs Healthcare | TheraBead Compress Cervical and TheraBead Compress STD | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01148-1 |
| mdprc 057 09 19 000 | Vyaire Medical, Inc. | Medisorb Cannister 0.8kg | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01247-1 |
| mdprc 056 09 19 000 | Siemens Healthcare Diagnostics Inc. | Atellica UAS 800 Analyser and Atellica 1500 Automated Urinalysis System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01258-1 |
| mdprc 055 09 19 000 | Rocket Medical | Rocket FBS Amnioscopes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01188-1 |
| mdprc 054 09 19 000 | Roche Diagnostics | COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01252-1 |
| mdprc 053 09 19 000 | Mavidon Medical Products | LemonPrep 114gm tubes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01158-1 |
| mdprc 052 09 19 000 | Inomed Medizintechnik GmbH | C3 CryoProbe 2.1 mm sharp | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01301-1 |
| mdprc 051 09 19 000 | Beckman Coulter | REMISOL Advance | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01275-1 |
| mdprc 050 09 19 000 | Beckman Coulter | Various Assays | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01286-1 |
| mdprc 049 09 19 000 | Argon Medical Devices | Arterial Catheter Mini Kit 20ga x 6” | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01182-1 |
| mdprc 048 09 19 000 | Alcove Medical Inc. | Atomizer – EZ Spray | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01175-1 |
| mdprc 036 09 19 000 | Corin Limited | Metafix stem size 4 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01151-1 |
| mdprc 019 09 19 000 | Weinmann | Weinmann Adult MEDUCORE Multifunctional Electrodes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01173-1 |
| mdprc 018 09 19 000 | Beckman Coulter | SYNCHRON Systems Benzodiazepine (BNZG) Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01194-1 |
| mdprc 016 09 19 000 | ICU Medical, Inc. | Various Haemodynamic Monitoring Kits | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01119-1 |
| mdprc 015 09 19 000 | Ad-Tech | Ad-Tech Product Catalogue | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01138-1 |
| mdprc 008 09 19 001 | MAQUET Cardiopulmonary | Heater Unit HU 35, 230 V | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01168-1 |
| mdprc 003 09 19 000 | Limacorporate | Modulus, Modulus-R and Revision modular femoral stems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01174-1 |
| mdprc 038 08 18 001 | Medtronic | BIS Vista and BIS View Monitoring Systems | NCMDR |
| mdprc 012 07 19 001 | Varian Medical Systems | Stainless Steel Interstitial Needles, 17 Gauge | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01003-1 |
| mdprc 008 03 19 001 | Biomet 3i Inc. | 3.4mm Certain BellaTek Abutment, ILDAT3 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171233 |
| mdprc 089 05 19 001 | Apollo Endosurgery Inc. | Orbera Intragastric Balloon System and BIB Intragastric Balloon System | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00675-1 |
| mdprc 009 08 19 000 | SIEMENS | MAMMOMAT Revelation VC10 with Biopsy Option | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01129-1 |
| mdprc 008 08 19 000 | Mesa Laboratories, Inc. | EZTest H202 Biological Indicators | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01128-1 |
| mdprc 006 08 19 000 | Allergan services international Limited | Textured Breast Implants and Tissue Expanders | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01116-1 |
| mdprc 115 07 19 000 | Henry Schein, Inc. | KaVo RONDOflex Powder 27µm 1000g to be used with the KaVo RONDOFLEX plus 360 air abrasion system | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01123-1 |
| mdprc 104 07 19 000 | SIEMENS | SOMATOM Definition Edge , SOMATOM Definition AS, SOMATOM Definition Flash, with syngo | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01083-1 |
| mdprc 103 07 19 000 | SIEMENS | Biograph mCT and mCT Flow systems running PETsyngo VG70A | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01114-1 |
| mdprc 102 07 19 000 | Medicrea International. | PEEK Cervical Cages and PEEK Lumbar Cages | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01105-1 |
| mdprc 101 07 19 000 | Cooper Surgical, Inc. | TRANSWARMER Warming Infant Transport Mattresses. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01106-1 |
| mdprc 097 07 19 000 | SPIGGLE & THEIS Medizintechnik | Panetti ENT endoscopic ear instruments | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01102-1 |
| mdprc 096 07 19 000 | Radiometer America Inc | Radiometer ABL90FLEX blood gas analyser and Radiometer AQT90FLEX immunoassay analyser | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01093-1 |
| mdprc 077 07 19 000 | GE Healthcare | Fluorostar 7900 System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01085-1 |
| mdprc 076 07 19 000 | HEIDELBERG ENGINEERING GmbH | HEYEX 2 image management components of SPECTRALIS PC Software | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01065-1 |
| mdprc 075 07 19 000 | Phadia Ltd | ImmunoCAP Tryptase Control | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01091-1 |
| mdprc 074 07 19 000 | QIAGEN Ltd | QIAsymphony SP instrument (Software 5.0.3) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01096-1 |
| mdprc 031 03 19 001 | BioFire Diagnostics Inc. | FilmArray Gastrointestinal (GI) Panel. | NCMDR |
| mdprc 064 07 19 000 | Getinge | GETINGE Steam Steriliser | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01071-1 |
| mdprc 043 07 19 000 | Phadia Ltd | Phadia 1000 instrument | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01055-1 |
| mdprc 042 07 19 000 | Morcher GmbH | Morcher Capsular Tension Rings Type 13 Right, Type 13A Right and Type 13B Right | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00995-1 |
| mdprc 041 07 19 000 | BD Biosciences | BD Connecta Plus3 White (3 way stopcock) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01049-1 |
| mdprc 038 07 19 000 | GE Healthcare | MAC VU360 systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01054-1 |
| mdprc 026 07 19 000 | Nuvasive Specialized Orthopaedics Inc. | MAGEC System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01014-1 |
| mdprc 025 07 19 000 | Cyclomedica Australia Pty Ltd | TechnegasPlus Generator | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01023-1 |
| mdprc 058 05 19 001 | Siemens Healthcare Diagnostics | Creatine Kinase on the Atellica Chemistry platform | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173277 |
| mdprc 011 07 19 000 | Beckman Coulter | AQUIOS IMMUNO-TROL Low Cells | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01033-1 |
| mdprc 037 05 19 001 | Baxter Healthcare | Prismaflex devices with software version 8.10 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00691-1 |
| mdprc 092 06 19 000 | Medical Innovation Developpement SAS | MID-Tube, Orogastric calibration Tube | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00985-1 |
| mdprc 089 06 19 000 | Arjo Huntleigh | Tenor Passive Floor Lift | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00978-1 |
| mdprc 018 06 19 001 | Teleflex Medical | Sheridan Endotracheal Tubes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173225 |
| mdprc 069 06 19 000 | RSR Ltd | ACHRAb RIA kits. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00918-1 |
| mdprc 068 06 19 000 | Zimmer | Comprehensive Reverse Shoulder Instrument Cases | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00922-1 |
| mdprc 050 06 19 001 | Becton Dickinson & Co. (BD) | Microtainer Tubes | Swissmedic |
| mdprc 053 06 19 000 | Terumo BCT Inc | Spectra Optia Apheresis System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00878-1 |
| mdprc 052 06 19 000 | Randox Laboratories Ltd. | Assayed Bovine Multi-Sera - Level 1 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00917-1 |
| mdprc 051 06 19 000 | Magic Mobility | Magic mobility wheelchair - Mobility Handles | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00907-1 |
| mdprc 049 06 19 000 | Beckman Coulter | SYNCHRON Systems Phosphorus Reagent (PHOSm) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00916-1 |
| mdprc 083 04 19 001 | Accuray Inc. | CyberKnife M6 and CyberKnife VSI Secondary Collimation Subsystem | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172287 |
| mdprc 017 06 19 000 | QIAGEN Ltd | Filter-Tips, 1500 µl (1024) used with QIAsymphony SP/AS Instruments | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00857-1 |
| mdprc 016 06 19 000 | Philips Healthcare | Philips Incisive Computed Tomography x-ray system | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00847-1 |
| mdprc 015 06 19 000 | CODAN Medizinische Geraete GmbH & Co KG | Codan Extension Set | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00813-1 |
| mdprc 014 06 19 000 | Nanjing Mindray Bio-Medical Electronics Co., Ltd. | HyLED Surgical Light Series 7, 8 and 9 | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00764-1 |
| mdprc 013 06 19 000 | Pride Mobility Products Ltd | J623 Power Wheel Chairs ("Jazzy 623") fitted with Dynamic Controls Shark Power Module | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00797-1 |
| mdprc 012 06 19 000 | Beckman Coulter UK Ltd | UniCel DxH 800/600/900 Coulter Cellular Analysis System. | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00808-1 |
| mdprc 056 08 18 001 | Beckman Coulter Inc.. | UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171361 |
| mdprc 114 05 19 000 | Aidacare Pty Ltd | Tilt & Recline Shower Commode: Aspire, 46cm and 53cm | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00736-1 |
| mdprc 113 05 19 000 | GE Healthcare | LVivo EF app on Vscan Extend | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00765-1 |
| mdprc 112 05 19 000 | Nidek Co. Ltd. | CEM-530 Specular Microscope | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00789-1 |
| mdprc 111 05 19 000 | SIEMENS | MAGNETOM Vida and Sola with syngo MR XA11 software | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00773-1 |
| mdprc 113 04 19 001 | Integra LifeSciences | LimiTorr Volume Limiting External CSF Drainage and Monitoring Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172225 |
| mdprc 092 05 19 000 | Change Healthcare | McKesson Cardiology Hemo Systems | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00745-1 |
| mdprc 091 05 19 000 | Medicina | ENFit NGP and Ryles Nasogastric Feeding Tubes | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00754-1 |
| mdprc 081 05 19 000 | Ivor Shaw Limited As Peninne Healthcare | Various Gastric Tubes and Catheters | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00746-1 |
| mdprc 059 05 19 000 | Siemens Healthcare Diagnostics | Creatine Kinase on the ADVIA Chemistry platform | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00732-1 |
| mdprc 057 05 19 000 | Medtronic | O-Arm 1000 Imaging Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00728-1 |
| mdprc 115 04 19 001 | MacoPharma | ACDA Anticoagulant Solution | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00633-1 |
| mdprc 059 08 18 001 | Air Liquide Medical Systems | Matrx Digital MDM Mixer | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00663-1 |
| mdprc 038 05 19 000 | MAKO Surgical | 2.7 Degree Angled Sagittal Saw attachment and 2.7 Degree Straight Sagittal Saw attachment | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00680-1 |
| mdprc 078 04 19 001 | Boston Scientific | Auriga 30 Laser System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00565-1 |
| mdprc 061 04 19 001 | Arc Laser GmbH | Wolf 445nm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00550-1 |
| mdprc 028 05 19 000 | Edwards Lifesciences | lntroFlex lntroducers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00683-1 |
| mdprc 026 05 19 000 | Beckman Coulter | IMMAGE Immunochemistry Systems Immunoglobulin M (IGM) Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00688-1 |
| mdprc 021 05 19 000 | Sysmex Corporation | Sysmex SP-50 slidemaker-stainer | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00672-1 |
| mdprc 020 05 19 000 | SIEMENS | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.All, SOMATOM go.Top | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00667-1 |
| mdprc 019 05 19 000 | Covidien | Monoject Standard Hypodermic Needles | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00671-1 |
| mdprc 009 05 19 000 | Zimmer | Alvarado Knee Holder Base Plate Assemblies and Foot Pieces and Alvarado II Base Plates and Foot Pieces | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00660-1 |
| mdprc 146 04 19 000 | SIEMENS | Biograph Vision 600 and Biograph Vision 600 Edge (with VG75A or B software and the PATLAK reconstruction license) | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00650-1 |
| mdprc 111 04 19 001 | Carestream Health | Carestream Onsight 3D Extremity System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171699 |
| mdprc 084 04 19 001 | Cook Medical | Pericardiocentesis Catheter Set | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00568-1 |
| mdprc 062 04 19 001 | Beaver Visitec International Ltd | Visiwipe Instrument Wipe 73 x 73mm | BfArM |
| mdprc 116 04 19 000 | Teleflex Medical | Rüsch Lasertubes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00606-1 |
| mdprc 114 04 19 000 | Istanbul Medikal Ltd | Medwarm neonate and Medwarm neonate with Skin temp port and probe | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00643-1 |
| mdprc 112 04 19 000 | DiaSorin Inc. | Liaison XL and Liaison XL LAS with POM Stirrer Bar M | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00579-1 |
| mdprc 097 04 19 000 | Stryker | Berchtold CHROMOPHARE F 528 and F 628 Surgical Light System Light Head Covers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00575-1 |
| mdprc 086 04 19 000 | Oxoid Ltd | OXOID MICE Strip MA0122 – Ceftriaxone32 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00573-1 |
| mdprc 085 04 19 000 | Direct Healthcare Services Ltd | Mercury Advance V1 Control Unit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00563-1 |
| mdprc 082 04 19 000 | Abbott | TactiSys Quartz Equipment operating | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00571-1 |
| mdprc 079 04 19 000 | Cincinnati Sub-Zero Products Inc. | CSZ Haemotherm 400CE System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00565-1 |
| mdprc 077 04 19 000 | Baxter Healthcare | Microbore Y-Type Extension Set and Catheter Extension Set with Clearlink | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00567-1 |
| mdprc 052 04 19 000 | Delfi Medical Innovations Inc. | VariFit Sterile Single Use Adult Thigh Cuffs, Single Port, Single Bladder | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00548-1 |
| mdprc 018 04 19 000 | Welch Allyn | TM55 Stress Testing Treadmills | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00484-1 |
| mdprc 099 03 19 000 | Medtronic SA | Drill Mini-Trephination 2.0mm | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00503-1 |
| mdprc 098 03 19 000 | Edwards Lifesciences | Miller and Fogarty Atrioseptostomy Catheters | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00499-1 |
| mdprc 087 03 19 000 | Biomet Spain Orthopaedics SL | Polished Finned 1 Piece Tibial Tray 71mm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00451-1 |
| mdprc 077 03 19 000 | Topcon Corporation | IMAGEnet 6 Ophthalmic Data System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00440-1 |
| mdprc 069 03 19 000 | Alba Bioscience | ALBAclone Anti-Leb Reagents | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00248-1 |
| mdprc 068 03 19 000 | Edwards Lifesciences | VAMP Optima Blood Sampling System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00433-1 |
| mdprc 067 03 19 000 | Medtronic | A610 DBS Clinician Programmer Application | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00428-1 |
| mdprc 065 03 19 000 | Draeger Medical Systems Inc. | Infinity Acute Care System (IACS) and Infinity M540 Stand Alone Monitor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00405-1 |
| mdprc 080 10 17 002 | Radiometer | Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00374-1 |
| mdprc 032 03 19 000 | bioMerieux Inc. | ChromID CPS/Horse Blood Agar | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00375-1 |
| mdprc 030 03 19 000 | Biocomposites Ltd | Genex Putty 5cc | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00380-1 |
| mdprc 017 03 19 000 | Phadia AB | ImmunoCAP ISAC sIgE 112 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00343-1 |
| mdprc 016 03 19 000 | Medtronic | Pulmonary Vein Ablation Catheter GOLD (PVAC GOLD) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00338-1 |
| mdprc 115 02 19 001 | Maquet Cardiopulmonary | Maquet Cardiopulmonary Pre-Bypass Filters used for Customised Tubing Packs | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00292-1 |
| mdprc 007 03 19 000 | Varian Medical Systems | Velocity Advanced Imaging [AI], Velocity Advanced Imaging Solutions [AIS] or VelocityGRID | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00142-1 |
| mdprc 049 10 18 001 | Baxter Healthcare | EXACTAMIX Empty EVA Bags | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00291-1 |
| mdprc 091 02 19 000 | Ardo medical AG | Ardo Sterile Tulips Nipple Shields, Medium and Large | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00259-1 |
| mdprc 027 12 18 001 | Shimadzu Medical Systems. | Digital Angiography System Trinias | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170548 |
| mdprc 088 02 19 000 | SIEMENS | Multiple SOMATOM CT Scanners - syngo CT VB10A with Option Dual Spiral Dual Energy | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00262-1 |
| mdprc 086 02 19 000 | Medrobotics Corporation | Obturator, short cone 7" and long cone 10" (an accessory to the Flex Rectoscope) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00261-1 |
| mdprc 084 02 19 000 | Beckman Coulter | Access Thyroglobulin Antibody II Reagents | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00238-1 |
| mdprc 077 02 19 000 | Varian Medical Systems | TrueBeam Radiotherapy System with Visual Coaching Device or EDGE or VitalBeam | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00147-1 |
| mdprc 076 02 19 000 | Stryker | Xia 3 Degen Tray and French Bender instrument | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00206-1 |
| mdprc 075 02 19 000 | Shimadzu Medical Systems. | Mobile X-Ray System MobileDaRt Evolution Handle | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00205-1 |
| mdprc 074 02 19 000 | Clearstream Technologies Ltd | Bard Lifestream Balloon Expandable Vascular Covered Stent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00175-1 |
| mdprc 060 02 19 000 | Varian Medical Systems | ARIA OIS for Radiation Oncology | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00169-1 |
| mdprc 059 02 19 000 | Randox Laboratories | Various Immunoassay Controls used with Siemens Immulite 2000 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00179-1 |
| mdprc 058 02 19 000 | Medrad Inc. | Radimetrics CDM Software | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00204-1 |
| mdprc 057 02 19 000 | GE Healthcare | Panda iRes Warmer with ResusView Heart Rate Feature | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00196-1 |
| mdprc 007 02 19 001 | Diagnostica Stago | STA – VWF:RCo reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00119-1 |
| mdprc 033 02 19 000 | FUJIFILM SonoSite, Inc | Sonosite L25 Needle Guide Bracket | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00034-1 |
| mdprc 032 02 19 000 | Ultradent Products, Inc. | UltraTemp & UltraTemp REZ | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00120-1 |
| mdprc 027 02 19 000 | Schulte-Elektronik | SISS BABYCONTROL Respiration Monitors | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00055-1 |
| mdprc 026 02 19 000 | Varian Medical Systems | VariSource HDR and GammaMed | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00140-1 |
| mdprc 025 02 19 000 | Edwards Lifesciences | Commander Delivery Systems. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00136-1 |
| mdprc 024 02 19 000 | Varian Medical Systems | ARIA Radiation Therapy Management | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00146-1 |
| mdprc 012 02 19 000 | Applied Medical Resources | 5x75mm Kii Fios Advanced Fixation Access System , | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00116-1 |
| mdprc 101 11 18 002 | Medtronic | Suction/Anticoagulation Assembly Lines | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169578 |
| mdprc 069 01 18 002 | Beckman Coulter | FC 500 Series Flow Cytometers | NCMDR |
| mdprc 130 10 18 001 | GE Healthcare | CARESCAPE R860 Inspiratory Safety Guard | NCMDR |
| mdprc 074 01 19 001 | bioMerieux Inc. | VITEK 2 - Card Pouch Integrity | NCMDR |
| mdprc 079 01 19 000 | Arthrex, Inc | BURR OVAL 12 FLUTE 5.5MM X 13CM , | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00101-1 |
| mdprc 076 01 19 000 | Shaoxing Fuqing Medical Products Co Ltd | Electronic Thermometer supplied in Tiny Tots First | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00085-1 |
| mdprc 075 01 19 000 | Edwards Lifesciences | Edwards Lifesciences IntraClude Intra-aortic Occlusion Device | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00086-1 |
| mdprc 056 01 19 001 | Medtronic | Programmer Software Update Supporting the Micra Transcatheter Pacing System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00079-1 |
| mdprc 055 01 19 000 | Cook Inc. | UNIVERSA Soft & Firm Ureteral Stent Sets, PTFE Wire Guide, Percutaneous Entry Set & Bander Ureteral Diversion Open-End Stent Set | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00068-1 |
| mdprc 013 01 19 001 | Immucor | Panocell-16 Kit | NCMDR |
| mdprc 014 01 19 000 | Limacorporate S.p.a. | Revision femoral neck H60mm lateralised + Screw | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00001-1 |
| mdprc 135 12 18 000 | Agilent Technologies, Inc. | Autostainer Slide Racks | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01606-1 |
| mdprc 133 12 18 000 | Getinge Disinfection AB | GETINGE XS32 Flat Screen Holder | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01602-1 |
| mdprc 046 05 17 001 | Natus Medical Inc. | neoBLUE blanket LED Phototherapy Systems , | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00043-1 |
| mdprc 106 12 18 000 | Olympus Winter & IBE GmbH | Various Olympus Grasping Forceps and Biopsy Forceps | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01556-1 |
| mdprc 104 12 18 000 | Medrad Inc. | Bayer Overhead Counterpoise mounting system | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01587-1 |
| mdprc 091 12 18 000 | Thermo Fisher Scientific Inc. | PP2001 HBA Agar Plates | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01562-1 |
| mdprc 090 12 18 000 | Stryker | Stryker Visum II LED Surgical Lighting system - EDS (Equipment Delivery System) Light Suspensions, Central Axis | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01555-1 |
| mdprc 089 12 18 000 | Stryker Communications | Stryker Visum II LED Surgical Lighting system - EDS (Equipment Delivery System) Light Suspensions, Central Axis | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01555-1 |
| mdprc 060 08 18 001 | MAKO Surgical Corp | Mako Vizadiscs and Vizadisc Hip Tracking Kit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01554-1 |
| mdprc 088 12 18 000 | Beckman Coulter | UniCel DxI 600 & 800 Access Immunoassay Systems & UniCel DxC 660i, 680i, 860i, 880i Synchron Access Clinical Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01564-1 |
| mdprc 087 12 18 000 | Amplitude | Anatomic Tibial Base Plate for fixed bearing insert cemented, Size 4 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01545-1 |
| mdprc 076 12 18 000 | SIEMENS | Biograph Horizon | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01547-1 |
| mdprc 075 12 18 000 | STEELCO | Steelco DS1000 washers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01540-1 |
| mdprc 074 12 18 000 | Rayner Intraocular Lenses Limited | RayOne Trifocal RAO603F + 10.5 D ADD 3.5 Intraocular Lens | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01538-1 |
| mdprc 073 12 18 000 | Novos Medical Systems Industry Trade Import and Export Ltd Co | Bililed Maxi+ Phototherapy Unit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01464-1 |
| mdprc 072 12 18 000 | DePuy | CORAIL Female Broaches (Size 9-20) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01495-1 |
| mdprc 071 12 18 000 | Becton, Dickinson And Company | BD Burette Sets | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01537-1 |
| mdprc 070 12 18 000 | B Braun Medical Inc. | Celsite Safety SST601F 6.5F SI - Access Ports | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01543-1 |
| mdprc 095 08 18 001 | Olympus | Olympus Bronchofiberscopes, Bronchovideoscopes, Bronchofibervideoscopes, Ultrasonic Bronchofibervideoscopes, Rhino-laryngo Videoscopes and Airway Mobilescopes | NCMDR |
| mdprc 059 12 18 000 | Microgenics Corp. | MAS Alcohol/Ammonia Control | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01530-1 |
| mdprc 002 12 18 002 | Medtronic | Medtronic HeartWare HVAD System Battery Charger | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169057 |
| mdprc 028 12 18 000 | Cis Bio International | Cisbio - Chromogranin A (CGA-ELISA) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01522-1 |
| mdprc 026 12 18 000 | Synovis Micro Companies Alliance Inc. | Synovis GEM4183C Coupler Forceps | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01519-1 |
| mdprc 018 12 18 000 | Hologic Inc. | I-View Contrast Enhanced Digital Mammography | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01515-1 |
| mdprc 017 12 18 000 | MED-EL Elektro-Medizinische Geraete GmbH | Sonata ti100 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01511-1 |
| mdprc 016 12 18 000 | SIEMENS | Syngo.plaza version VB30A_HF01 and previous software versions | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01509-1 |
| mdprc 015 12 18 000 | Stryker Neurovascular | Balloon Guide Catheters 9F | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01500-1 |
| mdprc 014 12 18 000 | Intuitive Surgical Inc. | da Vinci Xi Surgical System Arm Sensor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01501-1 |
| mdprc 003 12 18 000 | Optics Medical | Raindrop Near Vision Inlays | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01465-1 |
| mdprc 001 12 18 000 | Medicina | Medicina CG Nasogastric Tubes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01482-1 |
| mdprc 102 11 18 000 | RaySearch Laboratories | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7, and RayStation 8A | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01468-1 |
| mdprc 073 11 18 000 | Eurotrol B.V | HemoTrol Hemoglobin Controls | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01436-1 |
| mdprc 072 11 18 000 | GE Healthcare | Revolution CT Systems with SmartStep Option | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01452-1 |
| mdprc 071 11 18 000 | House With No Steps | FG107 Intravitreal Procedure Pack #1 and FG110 Intravitreal Procedure Pack #2A | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01442-1 |
| mdprc 070 11 18 000 | Misonix, Inc. | BoneScalpel and SonaStar FS1000 Ultrasonic Surgical Systems | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01444-1 |
| mdprc 055 11 18 000 | Diagnostica Stago | STACLOT LA (REF. 00600). | NCMDR |
| mdprc 038 11 18 000 | Carestream Health | Kodak DirectView DR 7500 System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01434-1 |
| mdprc 037 11 18 000 | Cambridge Nutritional Sciences Ltd | FoodPrint Microarray 200+ Food IgG. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01431-1 |
| mdprc 036 11 18 000 | BioArray Solutions Ltd. | HEA Precise Type Beadchip Kit and RHD Beadchip Kit, CE. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01435-1 |
| mdprc 017 11 18 000 | Argon Medical Devices | 4-Way Stopcock w/MLL, Adapter DBL Male and Female LL | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01423-1 |
| mdprc 005 11 18 000 | Carl Zeiss | Plex Elite 9000 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01414-1 |
| mdprc 152 10 18 000 | BioArray Solutions Ltd. | RHD BeadChip Kit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01399-1 |
| mdprc 132 10 18 000 | IRIS Diagnostics | iChemVELOCITY Urine Chemistry strips | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01395-1 |
| mdprc 131 10 18 000 | bioMerieux Inc. | NUCLISENS Lysis Buffer. An in vitro diagnostic medical device (IVD). | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01392-1 |
| mdprc 117 10 18 000 | Demeditec Diagnostics GmbH | Reverse T3 RIA | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01390-1 |
| mdprc 116 10 18 000 | Siemens Healthcare | Biograph mMR with software version syngo E11P when using BodyCOMPASS | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01388-1 |
| mdprc 112 10 18 000 | ICU Medical, Inc. | Lifeshield Primary Plum Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Tubing, Secure Lock 272 cm / 23 mL | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01375-1 |
| mdprc 111 10 18 000 | Paragon 28, Inc. | TITAN 3-D Wedge, Evans, Large, 10mm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01380-1 |
| mdprc 088 10 18 000 | LeMaitre Vascular | Pruitt F3-S Polyurethane Outlying Carotid Shunt | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01352-1 |
| mdprc 087 10 18 000 | Enterix Pty Ltd | ColoVantage Home-Faecal Immunochemical Test Kits. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01128-1 |
| mdprc 063 08 18 001 | Orthosensor Inc. | VERASENSE ZBH-PSNCREF311-R CR E-F/3-11 Right. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01135-1 |
| mdprc 048 10 18 000 | Belmont Instrument Corp | Buddy Disposable Sets | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01327-1 |
| mdprc 047 10 18 000 | Datascope Corp | CARDIOSAVE Intra-Aortic Balloon Pumps | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01317-1 |
| mdprc 046 10 18 000 | GE Healthcare | LOGIQ E10 ultrasound systems (when used with TEE probes) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01304-1 |
| mdprc 045 10 18 000 | Integra LifeSciences | CUSA Excel (Excel+) Ultrasonic Surgical Aspirator System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01324-1 |
| mdprc 044 10 18 000 | K2M Inc. | YUKON OCT Spinal System Polyaxial Screw Size 3.5 x 34mm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01326-1 |
| mdprc 043 10 18 000 | RaySearch Laboratories | RayStation and RayPlan | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01322-1 |
| mdprc 042 10 18 000 | Siemens Healthcare Diagnostics | Dimension Integrated Chemistry Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01328-1 |
| mdprc 041 10 18 000 | Siemens Healthcare Diagnostics | RAPIDPoint 500 Blood Gas Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01330-1 |
| mdprc 040 10 18 000 | SIEMENS | Biograph mCT and Biograph Horizon Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01329-1 |
| mdprc 018 05 17 001 | Abbott Medical Optics Inc. | Vitrectomy Cutter | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01301-1 |
| mdprc 031 10 18 000 | Medtronic | O-arm O2 Imaging Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01313-1 |
| mdprc 030 10 18 000 | TiSport | X-Short anti-tip tubes on certain TiLite manual wheelchairs | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01302-1 |
| mdprc 109 08 18 001 | Bio Rad | Pastorex Meningitis - reagent R4 (Streptococcus pneumoniae latex - green cap bottle). | Swissmedic Update |
| mdprc 088 09 18 000 | Abbott Laboratories | ARCHITECT ICT Modules | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01256-1 |
| mdprc 086 09 18 000 | Leica | BOND Slide Labeller Zebra Printer Power Supply Unit (PSU) for use with BOND-lll and BOND-MAX instruments. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01254-1 |
| mdprc 085 09 18 000 | Samsung Electronics | Samsung Digital X-Ray System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00982-1 |
| mdprc 084 09 18 000 | Siemens Healthcare Diagnostics | ADVIA Chemistry Creatine Kinase (CK_L) System Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01271-1 |
| mdprc 081 09 18 000 | Alcon Laboratories Inc. | CyPass Micro-Stents | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01228-1 |
| mdprc 080 09 18 000 | Bio Rad. | VIROTROL HIV-1 Ag | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01255-1 |
| mdprc 079 09 18 000 | Bio-Rad Laboratories | D-100 Haemoglobin Testing System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01239-1 |
| mdprc 104 08 18 001 | Siemens Healthcare Diagnostics | Aptio Automation and StreamLAB Automation. | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01181-1 |
| mdprc 110 08 18 000 | AGFA Corp. | DX-D 600 Digital Radiography Systems | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01140-1 |
| mdprc 108 08 18 000 | Cepheid | Xpert Xpress Flu/RSV assay | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01155-1 |
| mdprc 107 08 18 000 | CERNER | Cerner Dosage Calculator used via PowerOrders or Pharmacy Medication Manager | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01060-1 |
| mdprc 106 08 18 000 | Evolutis | Broach Handles for rasp used in orthopaedic surgery | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01127-1 |
| mdprc 105 08 18 000 | Permobil | M300 PS, C300 PS, C350 PS, C500 PS, (PS Seating only) | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01143-1 |
| mdprc 103 08 18 000 | Smiths Medical | Jelco ViaValve safety I.V. catheter | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01206-1 |
| mdprc 102 08 18 000 | Stryker | Hoffmann Limb Reconstruction Frame (LRF) System Hexapod Struts | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01203-1 |
| mdprc 101 08 18 000 | Therakos Inc. | Therakos Cellex Photopheresis System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01156-1 |
| mdprc 100 08 18 000 | TransMedics | Organ Care System (OCS) Heart system - OCS Heart Console | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01113-1 |
| mdprc 099 08 18 000 | Vision RT | AlignRT Plus/OSMS system | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01166-1 |
| mdprc 096 08 18 000 | Medtronic | Tools Database v1.288 CD | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01137-1 |
| mdprc 064 08 18 000 | SPATZ FGIA, INC.. | Spatz3 Adjustable Gastric Balloon System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01039-1 |
| mdprc 062 08 18 000 | Medtronic SA | Capnostream 20 and Capnostream 20p Bedside Patient Monitors | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01102-1 |
| mdprc 061 08 18 000 | Medical Components, Inc | Short Term Haemodialysis Catheters | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01084-1 |
| mdprc 058 08 18 000 | Stryker Europe | Hoffmann LRF Hexapod Software. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01118-1 |
| mdprc 057 08 18 000 | Sage In-Vitro Fertilization Inc | Various in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00594-1 |
| mdprc 041 08 18 000 | Medos Medizintechnik AG. | Deltastream Heater-Cooler Unit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00886-1 |
| mdprc 040 08 18 000 | Elekta Inc | MOSAIQ Medical Oncology version 2.64 SP3 and higher | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01070-1 |
| mdprc 039 08 18 000 | Draeger Medical Systems Inc | Dräger Ceiling Supply Unit; AGILA and Movita Lift Pendants | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01066-1 |
| mdprc 037 08 18 000 | Thermo Fisher Scientific Inc. | PP2030 Mannitol Salt Agar Plates. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01028-1 |
| mdprc 036 08 18 000 | Esaote S.p.A. | MyLab Alpha in combination with IH 6-18 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01043-1 |
| mdprc 011 03 18 001 | Natus Neurology | Natus NicoletOne 32Ch Ambulatory EEG Record System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164231 |
| mdprc 116 07 18 000 | Bio-Rad Laboratories Inc | IH-Com Fullversion & IH-Com for Reader | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01010-1 |
| mdprc 115 07 18 000 | Bio-Rad Laboratories Inc | CFX96-IVD Optical Reaction Module | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01004-1 |
| mdprc 102 07 18 000 | Integra LifeSciences | MAYFIELD Spine Table Adapters and Various Infinity XR2 Base Units | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00912-1 |
| mdprc 025 07 18 001 | B Braun Surgical SA | Safil Sutures | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00737-1 |
| mdprc 070 07 18 000 | LivaNova | Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00929-1 |
| mdprc 067 07 18 000 | Getinge Lancer | GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00906-1 |
| mdprc 054 07 18 000 | Elekta Inc. | Leksell GammaPlan 11.1 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00844-1 |
| mdprc 053 07 18 000 | Medtronic | Guardian Connect Mobile App | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00882-1 |
| mdprc 052 07 18 000 | Olympus | 10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00841-1 |
| mdprc 051 07 18 000 | Philips Healthcare | Patient Supports for Stitching | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00881-1 |
| mdprc 050 07 18 000 | Vygon | Nutriline and Nutriline Twinflo Peripherally inserted central catheters (PICC) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00842-1 |
| mdprc 049 07 18 000 | Vygon | Premicath Neonatal PICC with Stylet | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00478-1 |
| mdprc 026 07 18 000 | Ambu | AMBU Ultraseal II Anaesthetic Mask | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00799-1 |
| mdprc 024 07 18 000 | Baxter | In-Line Blood Set with Filter | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00783-1 |
| mdprc 023 07 18 000 | FUJIFILM | Synapse Cardiovascular (CV) Software | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00504-1 |
| mdprc 022 07 18 000 | Natus Medical | Xltek NeuroWorks Software | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00575-1 |
| mdprc 021 07 18 000 | NeoMed Inc. | NeoMed Enteral Feeding Tubes with EO Connectors | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00734-1 |
| mdprc 020 07 18 000 | NxStage Medical, Inc. | NxStage Express Fluid Warmer | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00798-1 |
| mdprc 019 07 18 000 | Starkey Laboratories | Earmoulds in use with children under 36 months | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00474-1 |
| mdprc 018 07 18 000 | Sunrise Medical | Zippie Zone Wheelchair | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00160-1 |
| mdprc 007 07 18 000 | Stryker Leibinger GmbH & Co.KG | QuikFlap Neuro Implants | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00682-1 |
| mdprc 006 07 18 000 | Zimmer Surgical Inc. | Dermatome AN | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00745-1 |
| mdprc 063 06 17 001 | Roche Diagnostics Corp | cobas omni MGP Reagent when used with cobas MPX assay (for use on the cobas 6800/8800 systems) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00744-1 |
| mdprc 050 06 18 000 | QIAGEN Ltd | EZ1 DSP Virus Kit (48) | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00659-1 |
| mdprc 049 06 18 000 | Medtronic SA | StraightShot Microdebrider Blades | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00675-1 |
| mdprc 048 06 18 000 | MAQUET Inc | VOLISTA STANOP, TRIPOD, ACCESS and QUICKLOCK Light heads | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00656-1 |
| mdprc 047 06 18 000 | Baxter Healthcare | FLOSEAL Special Applicator Tips | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00670-1 |
| mdprc 046 06 18 000 | SIEMENS | Symbia T and Symbia Intevo Systems Using CARE Dose4D Algorithms. | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00654-1 |
| mdprc 081 10 17 001 | Radiometer Inc. | Radiometer ABL800 series with FLEXQ module | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01316-1 |
| mdprc 142 05 18 000 | Stryker Orthopaedics | LFIT V40 Femoral Heads .. | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00639-1 |
| mdprc 124 05 18 000 | BioArray Solutions Ltd. | MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00403-1 |
| mdprc 123 05 18 000 | Biomet 3i Inc. | Tapered Screw-Vent Implants with 0.5 mm Machined Collar, MTX Surface and Microgrooves | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00509-1 |
| mdprc 122 05 18 000 | Phoenix Srl | Arcomed Volumed Set for Pump Type Volumed µVP 5005/7000 PVC and Gravity Use | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00367-1 |
| mdprc 121 05 18 000 | Remel Inc. | R30855101 - Salmonella paratyphi A-H Stained Suspension. | Medical supplies & Services Co.Ltd Mediserv |
| mdprc 114 06 16 001 | ConMed Corporation | CORE Suction Irrigation Handpieces | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00844-1 |
| mdprc 084 05 18 000 | Medtronic | Clip Gun Magazines | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00488-1 |
| mdprc 065 05 18 000 | Roche Diagnostics | Accu-Chek Inform II test | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00417-1 |
| mdprc 037 05 18 000 | Oxoid Ltd Div Thermo Fisher Scientific Inc. | OXOID AST DISC CT0159B – Oxacillin OX1 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00361-1 |
| mdprc 036 05 18 000 | O-Two Medical Technologies, Inc. | Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00406-1 |
| mdprc 035 05 18 000 | Ethicon Inc. | HARMONIC ACE + Shears with Adaptive Tissue Technology | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00446-1 |
| mdprc 013 05 18 000 | Dräger | Dräger Carina Ventilator | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00394-1 |
| mdprc 012 05 18 000 | Carl Zeiss | CLARUS 500 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00350-1 |
| mdprc 154 04 18 000 | FUJIFILM Corporation | FUJIFILM General X-ray System FDR Smart f series | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00351-1 |
| mdprc 153 04 18 000 | Medicina | Medicina Nasogastric Tubes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00269-1 |
| mdprc 152 04 18 000 | TriMed | Nitinol Staples / Elastic Staples - Large and Small Symmetrical | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00354-1 |
| mdprc 151 04 18 000 | Wright Medical | Aequalis Humeral Nail Drill Bit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00336-1 |
| mdprc 101 04 18 000 | Stryker Medtech | Sonopet Ultrasonic Products | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00323-1 |
| mdprc 100 04 18 000 | Gyrus ACMI | Classic Series Reusable Active Cord designed to be used with Gyrus ACMI FOCUS 640, Bovie and other general purpose monopolar electrosurgical generators | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00326-1 |
| mdprc 092 04 18 000 | Edwards Lifesciences | IntraClude Intra-aortic Occlusion Device | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00313-1 |
| mdprc 091 04 18 000 | Phadia AB | EliA Intrinsic Factor Well | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00317-1 |
| mdprc 090 04 18 000 | Philips Healthcare | Philips Ingenuity Core (728321) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00312-1 |
| mdprc 058 03 17 001 | CareFusion | Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00350-1 |
| mdprc 029 03 18 001 | Medtronic | MindFrame Capture LP Devices | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00194-2 |
| mdprc 020 04 18 000 | Getinge Sterilization AB | Getinge Sterilizer | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00196-1 |
| mdprc 019 04 18 000 | Welch Allyn | Spot Vision Screener 100 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00138-1 |
| mdprc 049 03 18 002 | Deerfield Imaging | IMRIS ORT100 and ORT300 Operating Room Tables | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162121 |
| mdprc 118 03 18 000 | Medtronic | Covidien LigaSure Exact Dissector Nano-Coated 20.6mm-21cm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00261-1 |
| mdprc 117 03 18 000 | Remel Inc. | Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2mL. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00201-1 |
| mdprc 116 03 18 000 | Well Lead Medical Co Ltd | Elongated Adult Non Rebreathe Mask | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00260-1 |
| mdprc 114 03 18 000 | HemoCue AB | HemoCue WBC Diff analysers and WBC Diff Microcuvettes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00161-1 |
| mdprc 077 03 18 000 | Philips Healthcare | Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00233-1 |
| mdprc 076 03 18 000 | Zimmer Biomet, Inc. | EBI OsteoGen Implantable Bone Growth Stimulator | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00210-1 |
| mdprc 074 03 18 000 | Intuitive Surgical Inc. | da Vinci X Patient Side Cart Arm Controller Joint Circuit Boards | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00231-1 |
| mdprc 073 03 18 000 | Transonic Systems Inc. | ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Set | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00220-1 |
| mdprc 100 08 17 001 | Beckman Coulter | AQUIOS CL Flow Cytometry System. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01101-1 |
| mdprc 048 03 18 000 | Sofradim Production | Versate Monofilament Mesh, 50x50 cm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00191-1 |
| mdprc 039 03 18 000 | Evolutis | HACTIV Calcar reamers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00156-1 |
| mdprc 090 12 17 001 | Siemens Healthcare Diagnostics | IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01516-1 |
| mdprc 004 03 18 000 | 3M Health Care Ltd | Futuro Quick Strap Ankle Support | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00098-1 |
| mdprc 003 03 18 000 | Cook Medical | Cook Aspiration Unit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00174-1 |
| mdprc 002 03 18 000 | Jolife AB | LUCAS 2 Chest Compression System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00147-1 |
| mdprc 001 03 18 000 | Tae-Chang Industrial Co. | U-100 Insulin Syringe 0.5mL 27G and 29G | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00171-1 |
| mdprc 061 01 18 001 | Allen Medical Systems | Radiolucent Spine Surgery Frame | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00024-1 |
| mdprc 089 02 18 000 | Arjo Huntleigh | Enterprise and Citadel Range Beds | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01199-1 |
| mdprc 088 02 18 000 | Mathys Ltd Bettlach | balanSys UNI convex PE inlay x/6, x/7, x/9 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00096-1 |
| mdprc 086 02 18 000 | SIEMENS | Biograph Horizon with VJ20A Software | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00126-1 |
| mdprc 085 02 18 000 | Southwest Technologies | Hypothermia Caps, Mittens and Slippers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00121-1 |
| mdprc 077 02 18 000 | SPINEART | Small Pedicle Probe ELL-IN 02 23-N | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00087-1 |
| mdprc 076 02 18 000 | SIEMENS | Biograph mMR with software version syngo E11P | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00113-1 |
| mdprc 075 02 18 000 | SIEMENS | ACUSON SC2000 ultrasound systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00115-1 |
| mdprc 074 02 18 000 | MAQUET Inc | Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00120-1 |
| mdprc 073 02 18 000 | Life Technologies Limited. | Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00125-1 |
| mdprc 072 02 18 000 | Beckman Coulter | Automate 1250 and 2550 Sample Processing Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00084-1 |
| mdprc 033 02 18 000 | Signature Orthopaedics | Signature Ceramic Femoral Head | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00091-1 |
| mdprc 032 02 18 000 | Siemens Healthcare Diagnostics | Dimension Vista Calcium (CA) Flex reagent cartridge. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00106-1 |
| mdprc 031 02 18 000 | Medline Industries Inc. | Unomedical ConvaTec Frazier Suction Handle (included in Foot Pack Health and Lower Extremity Procedure Packs) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00104-1 |
| mdprc 027 02 18 000 | Coloplast A/S | Biatain Ag Cavity Filler | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00086-1 |
| mdprc 026 02 18 000 | Medtronic | Valleylab FT10 energy platform | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00094-1 |
| mdprc 001 02 18 000 | GCMedica Enterprise Ltd | Fraizer suction handle | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00061-1 |
| mdprc 091 05 17 001 | Zimmer inc. | Affixus Hip Fracture Nail | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00559-1 |
| mdprc 092 12 17 002 | Greiner Bio-One Inc | Vacuette Minicollect Complete 1mL Sodium Citrate 3.2%. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01505-1 |
| mdprc 084 01 18 000 | QIAGEN Ltd | therascreen PyroMark Gold Q24 Reagents and Pyro Buffers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00069-1 |
| mdprc 079 01 18 000 | SIEMENS | Artis one systems in conjunction with Artis tables | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00054-1 |
| mdprc 076 01 18 000 | HOLOGIC | Panther and Panther Fusion Systems with 19-in monitor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00065-1 |
| mdprc 075 01 18 000 | Moog Inc. | Moog Infusion System Administration Sets | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00053-1 |
| mdprc 059 01 18 000 | Ningbo Runyes Medical Instrument Co Ltd | Runyes Autoclave | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00001-1 |
| mdprc 057 01 18 000 | Tornier Inc. | Multiple Tibial Implants | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00008-1 |
| mdprc 056 01 18 000 | DePuy Orthopaedics, Inc. | SIGMA HP Cemented Trochlea Implants | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00005-1 |
| mdprc 055 01 18 000 | COUSIN BIOTECH | NAJA Spinal Ligament Systems for Spinal Stabilization | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00007-1 |
| mdprc 053 01 18 000 | Beckman Coulter | Synchron Enzyme Validator | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00018-1 |
| mdprc 039 01 18 000 | Salter Labs | Oxygen Cannulas | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01545-1 |
| mdprc 117 12 17 000 | Philips Healthcare | Ingenuity TF PET/CT | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01541-1 |
| mdprc 107 12 17 000 | BioMerieux Inc. | ETEST Teicoplanin 256 (TP) SPB and Foam packaging. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01530-1 |
| mdprc 106 12 17 000 | Coloplast | Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Sling | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01542-1 |
| mdprc 105 12 17 000 | Medos International SARL | DePuy Synthes Confidence Kit Spinal Cement System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01534-1 |
| mdprc 104 12 17 000 | SynCardia Systems Inc. | SynCardia Freedom Driver System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01528-1 |
| mdprc 096 12 17 000 | BEKA Hospitec GmbH | C- Series lifts | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01450-1 |
| mdprc 095 12 17 000 | Boston Scientific | Nv Guider Catheter 90cm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01517-1 |
| mdprc 094 12 17 000 | Boston Scientific | Uphold LITE with Capio SLIM and Solyx Single Incision Sling System , | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01508-1 |
| mdprc 093 12 17 000 | Cook Inc. | Transseptal Needle | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01503-1 |
| mdprc 091 12 17 000 | O-Two Medical Technologies, Inc. | Equinox Advantage- Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01485-1 |
| mdprc 050 12 17 000 | MAKO Surgical Corp | MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01493-1 |
| mdprc 049 12 17 000 | Waverley Glen Systems Ltd | C-Series Lifts | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01442-1 |
| mdprc 048 12 17 000 | R & R Healthcare Equipment Pty Ltd | Hercules Patient Lifter | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01492-1 |
| mdprc 046 12 17 000 | Dako North America Inc. | Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01482-1 |
| mdprc 045 12 17 000 | BioArray Solutions Ltd | MIA FORA NGS HLA FLEX 11 KIT (24 tests). | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01491-1 |
| mdprc 023 12 17 000 | AirSep Corporation | Airsep Impulse Elite | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01448-1 |
| mdprc 022 12 17 000 | Edwards Lifesciences | Intro-Flex Automatic Hemostasis Valve Introducer | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01488-1 |
| mdprc 021 12 17 000 | Balt Extrusion | Balt Cristal Balloons | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01483-1 |
| mdprc 020 12 17 000 | Cook Medical | Various Vital-Port Vascular Access Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01453-1 |
| mdprc 019 12 17 000 | Phadia Ltd | Phadia Prime with software up to and including version 2.1.4 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01452-1 |
| mdprc 011 12 17 000 | Intelerad Medical Systems Inc. | IntelePACS with software versions 4-3-1 and up | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01434-1 |
| mdprc 005 12 17 000 | RaySearch Laboratories AB | RayStation and RayPlan | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01436-1 |
| mdprc 012 06 17 001 | Siemens Healthcare Diagnostics | N Antiserum to Human Ceruloplasmin | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156195 |
| mdprc 121 11 17 000 | Beckman Coulter… | Remisol Advance Software Versions Used with Abbott Architect Instruments | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01404-1 |
| mdprc 120 11 17 000 | Covidien LLC | Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilators | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01429-1 |
| mdprc 119 11 17 000 | Global Manufacturing Technology | Global Cup Poly Liner, Neutral prostheses | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01262-1 |
| mdprc 118 11 17 000 | Implant Direct Sybron Manufacturing,LLC | Spectra System/Legacy Guided Surgery Handle Kit Inserts | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01423-1 |
| mdprc 117 11 17 000 | Life Technologies Corporation | Foetal Haemoglobin Monoclonal Antibody (HBF-1). | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01414-1 |
| mdprc 116 11 17 000 | Seqirus Pty Ltd | Epiclone Anti-M Blood Grouping Reagent. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00817-1 |
| mdprc 115 11 17 000 | Seqirus Pty Ltd | Epiclone Anti-M Blood Grouping Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01361-1 |
| mdprc 114 11 17 000 | Stryker Howmedica Osteonics Corp | METS Principal Shaft | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01412-1 |
| mdprc 060 11 17 000 | William Cook Europe ApS | Disposable Reuter Tip-Deflecting Wire Guide | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01390-1 |
| mdprc 001 09 14 001 | Siemens Healthcare Diagnostics GmbH | Dimension Vista Hemoglobin A1c (HbA1c) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01393-1 |
| mdprc 059 11 17 000 | Remel Inc. | Thermofisher Remel Bactipstaph Latex Kits | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01410-1 |
| mdprc 058 11 17 000 | Physio Control Inc | Infant/Child Reduced Energy Defibrillation Electrodes Used with LIFEPAK Automatic External Defibrillators | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01389-1 |
| mdprc 057 11 17 000 | Hill-Rom, Inc. &Subsidiaries | Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), | Arabian Medical Marketing Co. (AMCO) |
| mdprc 056 11 17 000 | Beckman Coulter | DxH 500 Open-Vial Haematology System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01401-1 |
| mdprc 055 11 17 000 | DePuy International Limited | Acetabular Cup Introducer | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01385-1 |
| mdprc 054 11 17 000 | LivaNova Deutschland GmbH. | Sorin Group perfusion system – Heater Cooler 1T devices | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01370-1 |
| mdprc 053 11 17 000 | LivaNova Deutschland GmbH. | Sorin Group perfusion system – Heater Cooler 3T devices | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01368-1 |
| mdprc 011 11 17 000 | Actelion Pharmaceuticals | Veletri Consumables Kit with non Flow-Stop CADD Medication Cassette Reservoirs | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01369-1 |
| mdprc 010 11 17 000 | AGFA Corp. | Drystar DT 2 C Hardcopy Film 14" x 17" | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01371-1 |
| mdprc 009 11 17 000 | Dako Denmark A/S | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01330-1 |
| mdprc 002 11 17 000 | Stryker | rHead Radial Head and Uni-Elbow System | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01347-1 |
| mdprc 118 10 17 000 | Hospira Inc. | Plum 360 Infusion System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01335-1 |
| mdprc 105 10 17 000 | BioArray Solutions Ltd | MIA FORA NGS | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01303-1 |
| mdprc 104 10 17 000 | Fresenius | Dialysis Treatment Therapy Pack 105 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01341-1 |
| mdprc 099 10 17 000 | Zevex International Inc. | Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01324-1 |
| mdprc 098 10 17 000 | Stryker | Thoracic Pedicle Feeler | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01337-1 |
| mdprc 097 10 17 000 | Hospira Inc | Hospira labelled MedNet Medication Management Suite – with Plum 360 Infusion System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01336-1 |
| mdprc 082 10 17 000 | Sunrise Medical | Oxford Dipper Hoist | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01233-1 |
| mdprc 079 10 17 000 | Liko AB | Liko Multirall 200 overhead lift and S65 Carriage | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01289-1 |
| mdprc 073 10 17 000 | Biomet 3i Inc. | Abut Gold Friction-Fit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00896-1 |
| mdprc 072 10 17 000 | Cepheid | Xpert EV Assay | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01257-1 |
| mdprc 071 10 17 000 | ICU Medical, Inc. | Various Safeset and Transpac Blood Pressure Transducer Sets | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01237-1 |
| mdprc 070 10 17 000 | Medtronic | O-arm O2 Surgical Imaging System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01243-1 |
| mdprc 048 10 17 000 | MEDIPLAST AB | Various Disposable Catheter Mounts | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01268-1 |
| mdprc 047 10 17 000 | Sysmex America Inc | Fluorocell PLT reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01275-1 |
| mdprc 028 10 17 000 | Bard Pcripheral Vascular (BPV) | Max-Core Disposable Core Biopsy Instruments | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01238-1 |
| mdprc 027 10 17 000 | Boston Scientific | Auriga XL 4007 Laser System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01215-2 |
| mdprc 026 10 17 000 | Boston Scientific | Auriga XL 4007 Laser System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01213-1 |
| mdprc 025 10 17 000 | Hill-Rom | Progressa Bed System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01216-1 |
| mdprc 024 10 17 000 | Intelerad Medical Systems Inc. | IntelePACS InteleViewer | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01234-1 |
| mdprc 023 10 17 000 | SIEMENS | SOMATOM go.Up and SOMATOM go. Now | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01261-1 |
| mdprc 022 10 17 000 | SIEMENS | Multiple Artis systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01240-1 |
| mdprc 060 09 17 000 | iMDsoft Ltd | MetaVision ICU | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01173-2 |
| mdprc 059 09 17 000 | ThermoFisher Scientific Microbiology Perth | Oxoid AST Disc - Ceftazidime CAZ10 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01190-1 |
| mdprc 058 09 17 000 | St. Jude Medical Inc | NM Implantable Pulse Generator within the Infinity and Proclaim device families | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01184-1 |
| mdprc 057 09 17 000 | Siemens Medical Solutions | Artis zee and Artis Q systems with software version VD11C | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01186-1 |
| mdprc 056 09 17 000 | Radiometer America Inc | Radiometer AQT90FLEX Immunoassay analyser | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01195-1 |
| mdprc 055 09 17 000 | Oculentis | Lentis Foldable Intraocular Lenses (IOL) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01194-1 |
| mdprc 054 09 17 000 | Mediplas Respiratory Products Sdn Bhd | Various Disposable Catheter Mounts | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01168-1 |
| mdprc 053 09 17 000 | Immucor GmbH. | Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00997-1 |
| mdprc 052 09 17 000 | Gainsky Pty Ltd | Freedom Healthcare Quad Walkers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01130-1 |
| mdprc 051 09 17 000 | Bio-Rad Medical Diagnostics GmbH | DiaMed Q.C. System. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01183-1 |
| mdprc 033 09 17 000 | Philips Healthcare | IntelliVue Patient Monitors Performing 12-Lead ECG Monitoring | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01171-1 |
| mdprc 032 09 17 000 | Thermo Fisher Scientific. | TM0268 GC Sugar Set | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01157-1 |
| mdprc 031 09 17 000 | Smiths Medical | Graseby 3300 Pump and Graseby 3000 Series Accessories | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01146-1 |
| mdprc 030 09 17 000 | Pride Mobility Products Ltd | Iris Hi Lo Bed | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00842-1 |
| mdprc 103 08 17 001 | Thermo Fisher Scientific Inc. | Streptex Rapid Latex Agglutination Test. | Swissmedic |
| mdprc 013 09 17 000 | Bayer Healthcare LLC. | Essure Permanent Birth Control. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01125-1 |
| mdprc 012 09 17 000 | Stryker Howmedica Osteonics Corp | Mako THA Application User Guides | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01129-1 |
| mdprc 061 08 17 001 | Smith & Nephew inc | Polarstem Cardan for 21000438 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157987 |
| mdprc 011 09 17 000 | Siemens Medical Solutions | Artis one system with DP Transceiver below version 03 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01127-1 |
| mdprc 010 09 17 000 | Seqirus Pty Ltd | Epiclone Anti N BGR - Immunohaematology Reagent. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00754-1 |
| mdprc 009 09 17 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products Signal Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01090-1 |
| mdprc 008 09 17 000 | Hologic Inc | Affirm Lateral Arm Upright Biopsy Accessory (accessory to the Affirm Breast Biopsy Guidance System for Selenia Dimensions) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00988-1 |
| mdprc 102 08 17 000 | Thermo Fisher Scientific Inc. | Remel Wellcolex Colour Shigella Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01103-1 |
| mdprc 101 08 17 000 | Siemens Healthcare Diagnostics | Sysmex CS-5100 Analyser | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01098-1 |
| mdprc 099 08 17 000 | Applied Medical Resources | Kii Abdominal Troacar | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01102-1 |
| mdprc 063 08 17 000 | Vygon UK Ltd | XRO Umbilical Catheters | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01019-1 |
| mdprc 062 08 17 000 | The Binding Site | Human IgM kit for use on SPAPLUS | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00916-1 |
| mdprc 060 08 17 000 | Smith & Nephew inc. | D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-Tapping | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00925-1 |
| mdprc 059 08 17 000 | Safapac Ltd | S7XTRA Concentrate 5 Litre bottles | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00918-1 |
| mdprc 058 08 17 000 | PENTAX | Ultrasound Upper GI Video Scopes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00906-1 |
| mdprc 056 08 17 000 | Ortho-Clinical Diagnostics | VITROS Performance Verifier II | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01008-1 |
| mdprc 055 08 17 000 | Mediplas Respiratory Products Sdn Bhd | Disposable Expandable Adult 22mmID Expandable Anaesthetic Circuits | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01060-1 |
| mdprc 054 08 17 000 | Beckman Coulter | Gentian Cystatin C Calibrator Kit. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00992-1 |
| mdprc 053 08 17 000 | Abbott | Abbott RealTime HIV-1 Assay | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01057-1 |
| mdprc 052 08 17 000 | FUJIFILM Medical Systems | AMULET Digital Mammography Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00961-1 |
| mdprc 009 08 17 000 | Stanmore Implants | JTS System Grower Drive Units | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00865-1 |
| mdprc 008 08 17 000 | Olympus | HF-Resection Electrodes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00863-1 |
| mdprc 007 08 17 000 | Maquet | Heater Unit HU 35 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00917-1 |
| mdprc 006 08 17 000 | GE Healthcare | CareScape Patient Data Module (PDM) with software v2.6 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00873-1 |
| mdprc 005 08 17 000 | FUJIFILM Medical Systems | Fujifilm Digital Mammography System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00903-1 |
| mdprc 004 08 17 000 | C R Bard Inc. | ARCTIC SUN 5000 Temperature Management Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00534-1 |
| mdprc 003 08 17 000 | bioMerieux Inc. | Mueller Hinton E Agar (MHE) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00878-1 |
| mdprc 002 08 17 000 | Bayer Healthcare | Essure Permanent Birth Control System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00825-1 |
| mdprc 081 07 17 000 | Beckman Coulter | Synchron Systems Salicylate Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00844-1 |
| mdprc 080 07 17 000 | Alere LTD | Alere HIV Combo | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00856-1 |
| mdprc 079 07 17 000 | Baxter Corp Canada | HomeChoice and HomeChoice PRO Automated PD Cyclers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00855-1 |
| mdprc 078 07 17 000 | Cosman Medical | Nitinol RF Reusable Electrodes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00846-1 |
| mdprc 077 07 17 000 | MAKO Surgical Corp | Mako Internal cPCI Card Cage | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00857-1 |
| mdprc 076 07 17 000 | Siemens Healthcare Diagnostics GmbH | Dimension Clinical Chemistry System and Dimension Vista System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00839-1 |
| mdprc 075 07 17 000 | NOVO NORDISK A/S | NovoPen Echo | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00832-1 |
| mdprc 074 07 17 000 | R82 | Heron Toilet and Bath Chairs | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00858-1 |
| mdprc 072 07 17 000 | Tornier Inc | Aequalis Ascend Flex Shoulder System PTC Humeral Stems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00860-1 |
| mdprc 068 06 17 001 | Siemens Healthcare Diagnostics GmbH | Calibrator 30 (2 pack) used with ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, Centaur XP and Centaur XPT systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00747-1 |
| mdprc 031 07 17 000 | Sysmex Corporation | Sysmex CA-600 series with built-in barcode reader. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00807-1 |
| mdprc 030 07 17 000 | Roche Diagnostics | Sysmex XN-450, XN-550 & other XN-L series Automated Haematology Analysers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00828-1 |
| mdprc 029 07 17 000 | Olympus | Sealing Caps (A0282 and A0313) used with compatible endoscopy instruments | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00757-1 |
| mdprc 028 07 17 000 | Nortec NZ | Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip fastening | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00522-1 |
| mdprc 027 07 17 000 | MAQUET Cardiovascular LLC | Maquet/Datascope CS Intra-Aortic Balloon Pumps | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00834-1 |
| mdprc 026 07 17 000 | Intersurgical Limited | BVM Manual Manual Resuscitation Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00838-1 |
| mdprc 025 07 17 000 | ICU Medical, Inc. | Plum 360 Infusion Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00729-1 |
| mdprc 024 07 17 000 | CODAN | Codan Extension Set with T Connector, | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00821-1 |
| mdprc 023 07 17 000 | bioMerieux Inc | BK Virus R-gene Real-time Detection and Quantification Kit. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00806-1 |
| mdprc 022 07 17 000 | bioMerieux Inc. | Haemophilus Test medium (HTM). | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00831-1 |
| mdprc 021 07 17 000 | BioMerieux Inc. | BacT/ALERT BPN Culture Bottles | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00794-1 |
| mdprc 020 07 17 000 | Beckman Coulter | Pre-Transfusion Blood Testing System PK7300 Automated Microplate System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00798-1 |
| mdprc 019 07 17 000 | Beckman Coulter | COULTER LH and HmX Analyzers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00820-1 |
| mdprc 018 07 17 000 | Beckman Coulter | Recapper for the AutoMate 2500 Family. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00748-1 |
| mdprc 067 06 17 001 | St. Jude Medical Inc. | HeartMate 3 Left Ventricular Assist System (LVAS) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00750-1 |
| mdprc 070 06 17 000 | Beckman Coulter | Valproic Acid and Antibiotic TDM Multi-Calibrator | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00749-1 |
| mdprc 069 06 17 000 | MEDTECH SA | Rosa One 3.1 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2016-RN-01658-1 |
| mdprc 066 06 17 000 | Thermo Fisher Scientific Inc. | Various Microgenics Application Sheets. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00692-1 |
| mdprc 020 09 15 001 | Radiometer America Inc | ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00805-1 |
| mdprc 064 06 17 000 | Philips Healthcare | Philips IntelliVue MX40 Wearable Patient Monitors | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00732-1 |
| mdprc 062 06 17 000 | Seqirus Pty Ltd | Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00658-1 |
| mdprc 061 06 17 000 | Shimadzu Medical Systems | Shimadzu Ceiling Type X-ray Tube Support | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00698-1 |
| mdprc 060 06 17 000 | TransMedics | Organ Care System (OCS) Heart system | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00724-1 |
| mdprc 021 06 17 001 | Cook Medical | VueOptic Visualisation Source & Flexor Vue Deflecting Endoscopic System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155462 |
| mdprc 030 06 17 000 | Alcon LenSx, Inc | Alcon LuxOR LX3 Microscope Floor Stand | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00727-1 |
| mdprc 029 06 17 000 | Beckman Coulter | PrepPlus & PrepPlus 2 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00717-1 |
| mdprc 028 06 17 000 | Cook Endoscopy. | OptiLite Multi-Use Holmium Laser Fibers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00694-1 |
| mdprc 022 06 17 000 | Terumo BCT Inc | Various Terumo Introducer Kits | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00713-1 |
| mdprc 020 06 17 000 | Beckman Coulter | DxH 500 Haematology Analyser | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00705-1 |
| mdprc 019 06 17 000 | Tobrix BV. | Laser Guide, Endotherapy | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00707-1 |
| mdprc 011 06 17 000 | Siemens Healthcare Diagnostics | PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00678-1 |
| mdprc 122 05 17 001 | Zimmer inc. | Trauma Implants - intramedullary nails | NCMDR |
| mdprc 153 05 17 000 | Thermo Fisher Scientific Inc. | Dynabeads Reagents | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00645-1 |
| mdprc 152 05 17 000 | Siemens Healthcare Diagnostics | V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00533-1 |
| mdprc 151 05 17 000 | GE Healthcare | OEC Elite systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00643-1 |
| mdprc 150 05 17 000 | Applied Medical Resources | Kii abdominal trocars | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00636-1 |
| mdprc 149 05 17 000 | Alba Bioscience | ALBAclone Advanced Partial RhD Typing Kit. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00628-1 |
| mdprc 100 05 17 001 | Balt Extrusion | Microcatheter SONIC 1.5F | Swissmedic |
| mdprc 031 05 17 001 | SIEMENS | Sensis system | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154828 |
| mdprc 123 05 17 000 | Life Technologies Corporation | LABType DNA Typing Tests | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2016-RN-01380-1 |
| mdprc 095 05 17 001 | Medtronic SA | Polysorb Braided Absorbable Suture and EndoStitch Loading Unit with Polysorb Suture | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00589-1 |
| mdprc 114 05 17 000 | Diagnostica Stago | Asserachrom Von Willebrand Factor (VWF):Collagen (CB) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00588-1 |
| mdprc 101 05 17 000 | Abbott | ARCHITECT Free T4 Reagent. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00562-1 |
| mdprc 099 05 17 000 | Beckman Coulter Inc. | Synchron Systems Microalbumin (MA) Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00627-1 |
| mdprc 098 05 17 000 | Cook Inc, | Pereyra Ligature Carriers, Pereyra-Raz Ligature Carriers, and Stamey Needles | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00539-1 |
| mdprc 097 05 17 000 | Cook Medical | Endoscopic Curved Needle Driver, LapSac Introducer and LapSac Introducer Set | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00584-1 |
| mdprc 096 05 17 000 | Medline | Jackson-Pratt Perforated and Hemaduct Wound Drainage Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00565-1 |
| mdprc 094 05 17 000 | Nihon Kohden Corp. | Corpuls3 CO2 Disposable Naso-oral Adaptor Capone | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00535-1 |
| mdprc 093 05 17 000 | Sysmex America Inc. | XN-550 Hematology IVD Analyzers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00485-1 |
| mdprc 092 05 17 000 | Yafho Bio - Technology CO. Ltd | Ultrasound Probe Cover (Telescopic folded with gel) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00631-1 |
| mdprc 019 05 17 001 | Abbott Medical Optics Inc. | Healon Ophthalmic Viscoelastic Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154835 |
| mdprc 051 05 17 000 | Teleflex Medical | WECK Visistat 35R Skin Staplers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00508-1 |
| mdprc 050 05 17 000 | Stryker Communications | Visum LED Surgical Lighting system | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00455-1 |
| mdprc 049 05 17 000 | SIEMENS | SOMATOM Force with software version VA50A | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00487-1 |
| mdprc 048 05 17 000 | Parker Healthcare | TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00490-1 |
| mdprc 047 05 17 000 | Olympus | Monopolar HF Resection Electrodes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00498-1 |
| mdprc 045 05 17 000 | Cook Inc. | Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue Graft | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00328-1 |
| mdprc 044 05 17 000 | Caesarea Medical Electronics Ltd | BodyGuard Pump IV Administration Set | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00446-1 |
| mdprc 043 05 17 000 | Bausch & Lomb | EZ-Load Lens Delivery System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00520-1 |
| mdprc 035 05 17 000 | Vascular Solutions Inc. | Venture RX, OTW and CS Catheters | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00538-1 |
| mdprc 034 05 17 000 | Stryker | Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone Transport | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00531-1 |
| mdprc 025 05 17 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Centaur Systems Insulin Calibrators and ReadyPack Kits | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00488-1 |
| mdprc 022 05 17 000 | Quantel Medical | Laser photocoagulator Easyret | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00507-1 |
| mdprc 021 05 17 000 | Natus Medical Inc. | neoBLUE LED Phototherapy Lights (2nd Generation) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00466-1 |
| mdprc 020 05 17 000 | bioMerieux Inc. | VITEK 2 Identification / Antimicrobial Susceptibility Test Cards. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00523-1 |
| mdprc 035 02 17 001 | Covidien LLC | Valleylab Laparoscopic Handset, Four-Function | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00165-1 |
| mdprc 062 03 17 000 | William Cook | Cook Bush SL and Bush DL Ureteral Illuminating Catheters | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00365-1 |
| mdprc 061 03 17 000 | SIEMENS | Wireless Foot Switch utlised on Artis systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00325-1 |
| mdprc 060 03 17 000 | Kerr Corporation | Sealapex Xpress | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00314-1 |
| mdprc 059 03 17 000 | DiaSorin Inc. | Liaison C-Peptid Assay | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00323-1 |
| mdprc 053 03 17 000 | Philips Healthcare | BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00327-1 |
| mdprc 045 03 17 000 | Philips Healthcare | Philips Ingenuity CT system | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00261-1 |
| mdprc 044 03 17 000 | Philips Healthcare | Philips BrightView / BrightView X / BrightView XCT and BrightView X upgrade to XCT | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00260-1 |
| mdprc 043 03 17 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products VANC Reagent | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00302-1 |
| mdprc 042 03 17 000 | Getinge Disinfection AB | Getinge HS33 Sterilsers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00251-1 |
| mdprc 041 03 17 000 | Genesis Biotech Pty Ltd | PregSure Digital Pregnancy Test & Pregsure Pregnancy Test | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00230-1 |
| mdprc 040 03 17 000 | Ellex Medical | Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00213-1 |
| mdprc 039 03 17 000 | DePuy International Ltd | Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00304-1 |
| mdprc 038 03 17 000 | ConMed Corporation | ConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece Sheaths | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00293-1 |
| mdprc 037 03 17 000 | Aero Healthcare | Aerowound Combine Dressing ACD2040S, size 20cm x 40cm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00283-1 |
| mdprc 083 01 17 002 | Siemens Healthcare Diagnostics | Calibrator A used with ADVIA Centaur FT4 (free thyroxine) assay on the ADVIA Centaur, Centaur XP, Centaur XPT Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152666 |
| mdprc 044 02 17 000 | Siemens Healthcare Diagnostics | Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00196-1 |
| mdprc 043 02 17 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Centaur XPT System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00208-1 |
| mdprc 042 02 17 000 | Diagnostic Solutions Pty Ltd | ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00169-1 |
| mdprc 041 02 17 000 | BrainLAB | Brainlab Offset Cup Impactor Universal (blue handle) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00178-1 |
| mdprc 040 02 17 000 | Boston Scientific. | AngioJet Ultra 5000A Console - | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00183-1 |
| mdprc 039 02 17 000 | Abbott | StarClose SE Vascular Closure System (VCS) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00211-1 |
| mdprc 038 02 17 000 | Roche Diagnostics Ltd | Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00159-1 |
| mdprc 037 02 17 000 | Physio Control Inc. | LIFEPAK 1000 Automatic External Defibrillators | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00114-1 |
| mdprc 036 02 17 000 | IRIS Diagnostics | iChemVELOCITY Automated Urine Chemistry Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00170-1 |
| mdprc 013 06 16 001 | Roche Diagnostics Corp | ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00712-1 |
| mdprc 010 02 17 000 | Saraya Australia Pty Ltd | Acecide Test Strips | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00139-1 |
| mdprc 128 01 17 001 | Siemens Healthcare Diagnostics | Innovance D-Dimer assay run on Sysmex CS Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00112-1 |
| mdprc 134 01 17 000 | Roche Diagnostics Ltd | Sysmex XN-9000 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00089-1 |
| mdprc 133 01 17 000 | RaySearch Laboratories | RaySearch RayStation 4.5, 4.7, 5, and 6 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00133-1 |
| mdprc 132 01 17 000 | Radiometer Medical | Radiometer ABL800 Series Analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00137-1 |
| mdprc 131 01 17 000 | Radiometer Inc. | Radiometer ABL90 Series Analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00121-1 |
| mdprc 130 01 17 000 | Carestream Health | DRX Revolution Mobile X-Ray System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00085-1 |
| mdprc 129 01 17 000 | Abacus ALS Pty Ltd | IRT Screening Assay | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00087-1 |
| mdprc 127 01 17 000 | Physio Control Inc | Physio Control Inc | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00102-1 |
| mdprc 126 01 17 000 | Cepheid | Xpert BCR-ABL Monitor assay | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00083-1 |
| mdprc 069 09 14 001 | The Binding Site | Human IgG4 Kit Immage Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152025 |
| mdprc 084 01 17 000 | SIEMENS | Mammomat Inspiration System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00071-1 |
| mdprc 082 01 17 000 | ISOMed | Arterial Embolectomy Catheters – Single Lumen (2F & 3F) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00091-1 |
| mdprc 081 01 17 000 | Biomet Inc. | Comprehensive Reverse Shoulder Trays | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00021-1 |
| mdprc 080 01 17 000 | Biomet Inc. | Vanguard Open Box Femoral Components | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00055-1 |
| mdprc 079 01 17 000 | Abacus ALS Pty Ltd | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00063-1 |
| mdprc 147 10 16 001 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products Intact PTH Reagent Packs and Calibrators | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01318-1 |
| mdprc 056 01 17 000 | Philips Healthcare | Transpac 4 Disposable Pressure Transducer Monitoring Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00015-1 |
| mdprc 055 01 17 000 | Siemens Healthcare Diagnostics | ADVIA Centaur, Dimension Vista & Immulite Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00039-1 |
| mdprc 054 01 17 000 | Diagnostic Solutions Pty Ltd | Pak Lx Assay | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00056-1 |
| mdprc 022 01 17 000 | Siemens Healthcare Diagnostics | Dimension Clinical Chemistry System and Dimension Vista System , | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00002-1 |
| mdprc 021 01 17 000 | Hospira Inc | Plum 360 Infusion Pump | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00001-1 |
| mdprc 012 01 17 000 | Nucletron bv | Oncentra External Beam (formerly known as Oncentra MasterPlan during release of v3.x) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01655-1 |
| mdprc 011 01 17 000 | SCIENT’X | Arsenal Set-Screw | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01639-1 |
| mdprc 007 01 17 000 | Bard Pcripheral Vascular (BPV) | Bard StatLock Catheter Stabilisation Device | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01605-1 |
| mdprc 006 01 17 000 | CareFusion.. | SmartSite Add-On Bag Access Devices | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01631-1 |
| mdprc 005 01 17 000 | ConMed Corporation | Conmed GS2000 - 50L Abdominal Insufflator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01601-1 |
| mdprc 004 01 17 000 | Hill Rom Inc | Medical Mattresses and Mattress Covers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01613-1 |
| mdprc 003 01 17 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products UPRO Slides . | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01627-1 |
| mdprc 002 01 17 000 | Shantex Pty Ltd | Vinyl examination/treatment glove, non-powdered | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01596-1 |
| mdprc 001 01 17 000 | SIEMENS | Dimension Vista V-LYTE Integrated Multisensor | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01652-1 |
| mdprc 126 12 16 000 | Ortho-Clinical Diagnostics | Reagent Red Blood Cells 0.8% Resolve Panel C | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01599-1 |
| mdprc 125 12 16 000 | Hirtz & Co. KG. | HICO - Variotherm 550 Hypothermia/Hyperthermia Unit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01600-1 |
| mdprc 111 12 16 000 | Philips Healthcare | Philips MX 16-slice CT systems featured with Lung Nodule Analysis | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01603-1 |
| mdprc 110 12 16 000 | Philips | Ingenia 1 .5T and Ingenia 3.OT MR systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01595-1 |
| mdprc 109 12 16 000 | iNova Pharmaceuticals Australia Pty Ltd | Algerbrush II and Algerbrush II Accessories | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01586-1 |
| mdprc 108 12 16 000 | CareFusion | Alaris System PC Units | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01565-1 |
| mdprc 107 12 16 000 | Bio-Rad | ID-DC Screening II | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01574-1 |
| mdprc 106 12 16 000 | Beckman Coulter Inc | UniCel DxC Synchron Wash Concentrate II | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01619-1 |
| mdprc 120 11 16 001 | Bayer Healthcare LLC.. | Source Administration Sets Used with Medrad Intego PET Infusion Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01498-1 |
| mdprc 005 12 16 001 | Laerdal Medical As | Laerdal Compact Suction Unit 4 (LCSU 4) | NCMDR |
| mdprc 056 12 16 000 | Parker Healthcare | TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01577-1 |
| mdprc 055 12 16 000 | Abbott | Architect Active-B12 Reagent Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01579-1 |
| mdprc 054 12 16 000 | MAQUET Inc | Atrium Chest Drains | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01580-1 |
| mdprc 049 12 16 000 | Radiometer Medical | Radiometer ABL700 and ABL800 series blood gas analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01538-1 |
| mdprc 035 12 16 000 | Oventus Pty Ltd | O2Vent T. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01554-1 |
| mdprc 033 12 16 000 | Siemens Healthcare Diagnostics | CentraLink Data Management Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01576-1 |
| mdprc 032 12 16 000 | CareFusion 206 Inc, | Distraction Screws Packaged sterile | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01575-1 |
| mdprc 030 12 16 000 | Oventus Pty Ltd | O2vent T | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01572-1 |
| mdprc 009 12 16 000 | Siemens Healthcare Diagnostics Product | Immulite 2000 / Immulite 2000 XPi Intact Parathyroid Hormone (iPTH) assay. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01555-1 |
| mdprc 008 12 16 000 | Roche Diagnostics Corp | Homocysteine Enzymatic Assay used on Cobas Integra 400 plus/800 analysers and cobas c 501/502 & 701/702 modules | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01549-1 |
| mdprc 007 12 16 000 | Uniwide Australia Import Export Pty Ltd | Deluxe First Aid Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01515-1 |
| mdprc 020 10 15 002 | Ortho-Clinical Diagnostics | VITROS Chemistry Products Calibrator Kit 9 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01547-1 |
| mdprc 006 12 16 000 | Teleflex Medical | WECK Visistat 35W Skin Stapler | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01545-1 |
| mdprc 160 11 16 000 | Taylor Bio-Medical Pty Ltd | Quantum Blue Calprotectin Assay and Quantum Blue Calprotectin High Range | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01270-1 |
| mdprc 159 11 16 000 | Philips Burton | Philips Brilliance 64 and Ingenuity CT/Core/Core128. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01528-1 |
| mdprc 138 11 16 000 | Spacelabs Healthcare Inc | Spacelabs Healthcare Xhibit Central Station Model 96102 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00572-1 |
| mdprc 137 11 16 000 | Life Healthcare | Kasios TCP and Kages | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01443-1 |
| mdprc 119 10 16 001 | Roche Diagnostics Corp | Tina-quant Haemoglobin A1c Gen.2 used with COBAS INTEGRA 400 plus analyser | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150150 |
| mdprc 126 11 16 000 | Stryker Instruments | K-Wires for T2 and Gamma Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01469-1 |
| mdprc 125 11 16 000 | Surgical Specialties / Angiotech | ADVANCE HA Coated TitaniumTibial Bases | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00883-1 |
| mdprc 124 11 16 000 | Supergloves Australia Pty Ltd | Supergloves Vinyl Examination Gloves | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01481-1 |
| mdprc 123 11 16 000 | Radiometer America Inc | Pico 70 Arterial blood sampler. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01500-1 |
| mdprc 122 11 16 000 | Maquet Cardiopulmonary AG | MAQUET HLS and PLS Sets | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01514-1 |
| mdprc 121 11 16 000 | Life Healthcare | Neuro Flap Fix Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01497-1 |
| mdprc 119 11 16 000 | Stryker Orthopaedics | Offset Cup Reamer Handles | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01468-1 |
| mdprc 118 11 16 000 | Siemens Medical Solutions | SOMATOM Force. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01461-1 |
| mdprc 117 11 16 000 | In Vitro Technologies | Freelite Human Lambda Free kit for use on SPAPLUS | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01425-1 |
| mdprc 071 11 16 000 | Australian Comfort Group | Pressure Care Medical Mattresses and Mattress Covers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01408-1 |
| mdprc 069 11 16 000 | Beckman Coulter Inc | AU680 chemistry analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01426-1 |
| mdprc 068 11 16 000 | Draeger Medical Systems Inc | Infinity Acute Care Monitoring System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01412-1 |
| mdprc 067 11 16 000 | Elekta Business Area Software Systems IMPAC Medical Systems Inc. | Monaco .. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01421-1 |
| mdprc 066 11 16 000 | Endologix Inc | Nellix EndoVascular Aneurysm Sealing System. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01390-1 |
| mdprc 065 11 16 000 | Maquet Cardiopulmonary AG | Atrium Trocar Catheters, Sizes 8Fr to 32Fr | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01419-1 |
| mdprc 064 11 16 000 | Medtronic.. | ARRIVE Braided Transseptal Sheath | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01432-1 |
| mdprc 063 11 16 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products C-reactive protein (CRP) Slides | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01427-1 |
| mdprc 017 11 16 000 | Allegra Orthopaedics Limited | Active Knee Total Knee Replacement System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01395-1 |
| mdprc 148 10 16 000 | Siemens Healthcare Diagnostics GmbH | Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01374-1 |
| mdprc 145 10 16 000 | Honeywell | Honeywell | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01226-1 |
| mdprc 144 10 16 000 | Emergo Australia | RaySearch RayStation 5. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01364-1 |
| mdprc 143 10 16 000 | Bard Australia Pty Ltd | Bard Inlay Optima Ureteral Stents | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01369-1 |
| mdprc 120 10 16 000 | Siemens Healthcare Diagnostics GmbH | Aptio Automation Modules | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01310-1 |
| mdprc 118 10 16 000 | Philips Healthcare | IntelliVue MX40 Patient Monitors used with IntelliVue Information Centers iX | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01297-1 |
| mdprc 117 10 16 000 | Invacare Corporation…. | Invacare Birdie Lifters (Patient lifters) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01287-1 |
| mdprc 116 10 16 000 | In Vitro Technologies | Freelite Human Kappa Free Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01298-1 |
| mdprc 115 10 16 000 | Haemokinesis Pty Ltd | ALBAclone Advanced Partial RhD Typing Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01323-1 |
| mdprc 114 10 16 000 | Cepheid | Xpert HIV-1 Viral Load Assays | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01272-1 |
| mdprc 113 10 16 000 | Vision RT | AlignRT patient positioning/tracking video camera system | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00936-1 |
| mdprc 112 10 16 000 | Pro-Pac Packaging Aust Pty Ltd | Feather Touch Vinyl Examination Gloves | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01292-1 |
| mdprc 111 10 16 000 | Bard Access Systems | SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01314-1 |
| mdprc 058 10 16 000 | Siemens Healthcare Diagnostics GmbH | Automatic QC Cartridge tHb Level 1 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01237-1 |
| mdprc 036 10 16 000 | Philips Healthcare | Various Brilliance and Ingenuity Computed Tomography Systems... | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01196-2 |
| mdprc 035 10 16 000 | Hospira Inc | Plum 360 Infusion Pump. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01199-1 |
| mdprc 034 10 16 000 | Bosco Medical Australia | Pennine Healthcare Ryles Tubes | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01156-1 |
| mdprc 033 10 16 000 | Arthrex Inc | Arthrex ITD Articulating Arm 300 + 350MM | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01192-1 |
| mdprc 031 10 16 000 | ZOLL Medical Corp | AVOXimeter 1000E Cuvettes | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01265-1 |
| mdprc 030 10 16 000 | TIDI Products LLC | Zero-Gravity Radiation Protection Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01289-1 |
| mdprc 029 10 16 000 | Siemens Healthcare Diagnostics GmbH | Chemistry 1 Calibrator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01243-1 |
| mdprc 028 10 16 000 | Radiometer America Inc | Radiometer TCM5 Flex Monitor | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01264-1 |
| mdprc 027 10 16 000 | Ortho-Clinical Diagnostics | VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01254-1 |
| mdprc 026 10 16 000 | Elekta | Monaco V5.10 and V5.20 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01281-1 |
| mdprc 025 10 16 000 | Cynosure | Sterile Single Use Minor Surgery Bipolar Cable, IEC-BC | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01267-1 |
| mdprc 024 10 16 000 | B Braun Surgical SA | Spinocath G22 / G27 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01228-1 |
| mdprc 023 10 16 000 | Stryker Orthopaedics | LFIT V40 Femoral Heads. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01191-1 |
| mdprc 022 10 16 000 | Rehab Assist Pty Ltd | C-series carry bars | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01200-1 |
| mdprc 021 10 16 000 | Radiometer America Inc | Radiometer ABL90FLEX and ABL90FLEX PLUS Blood Gas Analyser | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01201-1 |
| mdprc 020 10 16 000 | Philips Healthcare | Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01183-1 |
| mdprc 019 10 16 000 | Getinge Disinfection AB | ED-FLOW and ED-FLOW SD Automated Endoscope Reprocessing Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01216-1 |
| mdprc 018 10 16 000 | Debriflo Pty Ltd | Debriflo Ultrasonic Wound Irrigation Hand-piece | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01165-1 |
| mdprc 017 10 16 000 | Beckman Coulter | AQUIOS CL Flow Cytometer System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01209-1 |
| mdprc 016 10 16 000 | Aero Healthcare | NIO-A device | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01138-1 |
| mdprc 015 10 16 000 | Siemens Medical Solutions | Iron Assay performed with the Dimension & Dimension Vista Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01186-1 |
| mdprc 014 10 16 000 | Siemens Healthcare Diagnostics | RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01187-1 |
| mdprc 013 10 16 000 | Roche Diagnostics Corp | Accu-Chek Connect Diabetes Management App for iPhone (iOS) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01168-1 |
| mdprc 012 10 16 000 | PANTHERA AB | Model S3 Wheelchairs | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01154-1 |
| mdprc 011 10 16 000 | Diagnostic Solutions Pty Ltd | FIDS dsDNA Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01184-1 |
| mdprc 010 10 16 000 | Abacus ALS Pty Ltd | Coxiella burnetii IFA IgG Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01149-1 |
| mdprc 032 09 16 001 | AMO Germany GmbH | TECNIS 1-Piece Intraocular Lens (IOL) with TECNIS iTEC Preloaded Delivery System PCB00 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01151-1 |
| mdprc 036 09 16 000 | Integra LifeSciences Corporation | Ventricular Catheter Accessory Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01139-1 |
| mdprc 035 09 16 000 | Hamilton Medical Inc | Hamilton Medical MR1 Ventilator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01133-1 |
| mdprc 034 09 16 000 | CareFusion 206 Inc, | Alaris GP Infusion set with Back Check Valve | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01153-1 |
| mdprc 033 09 16 000 | bioMerieux Inc | Sensitest Agar | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01142-1 |
| mdprc 140 08 16 000 | Siemens Healthcare Diagnostics Inc | Dimension & Dimension Vista Urine Opiates Screen assays. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01117-1 |
| mdprc 139 08 16 000 | ThermoFisher Scientific Microbiology Perth | Oxoid Antimicrobial Susceptibility Testing Disc - Ceftazidime CAZ10. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01115-1 |
| mdprc 138 08 16 000 | Medela AG | Medela breastpumps detachable wall plug component of AC Power Adaptor | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01069-1 |
| mdprc 137 08 16 000 | ConMed Corporation | Concept Heatwave Electrode | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01129-1 |
| mdprc 136 08 16 000 | Stryker Communications | Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01114-1 |
| mdprc 135 08 16 000 | Siemens Medical Solutions | syngo RT Therapist in combination with Oncology Information System (OIS) ARIA or MOSAIQ | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01088-1 |
| mdprc 134 08 16 000 | Siemens Healthcare Diagnostics | RAPIDLab and RAPIDPoint BloodGas Analyzers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01098-1 |
| mdprc 133 08 16 000 | Bard Pcripheral Vascular (BPV) | Bard EnCor Needle Guide Insert | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01101-1 |
| mdprc 132 08 16 000 | Siemens Healthcare Diagnostics Product | Sysmex CS-2000i and CS-2100i systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01073-1 |
| mdprc 139 05 16 001 | ConMed Corporation | ConMed ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146783 |
| mdprc 119 08 16 000 | Siemens Medical Solutions | Primus, ONCOR and ARTISTE | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01086-1 |
| mdprc 118 08 16 000 | Amplitude GmbH | Cemented resurfacing patellar implant, Ø 33mm and 36mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01013-1 |
| mdprc 049 08 16 001 | LeMaitre Vascular GmbH | 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm | TGA |
| mdprc 081 08 16 000 | Hill Rom Inc | Ceiling Bracket, Arch 71 White | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01014-1 |
| mdprc 080 08 16 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Centaur Systems Calibrator U (Myoglobin) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01056-1 |
| mdprc 079 08 16 000 | Lima Orthopaedics | Allen Wrench 5mm in SMR supplied in instrument set | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01053-1 |
| mdprc 078 08 16 000 | Imaxeon Pty Ltd | Certegra Workstation used in conjunction with Medrad Stellant CT Injection System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01064-1 |
| mdprc 077 08 16 000 | Emergo Asia Pacific Pty Ltd T/a Emergo Australia | IntelePACS InteleViewer.. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01045-1 |
| mdprc 076 08 16 000 | Bard Pcripheral Vascular (BPV) | BARD Toomey Irrigation Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01075-1 |
| mdprc 053 08 16 000 | Abacus ALS Pty Ltd | Cell Marque Rabbit Monoclonal Antibody. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01012-1 |
| mdprc 052 08 16 000 | Alere | INRatio and INRatio 2 PT/INR Monitor Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00999-1 |
| mdprc 051 08 16 000 | Beckman Coulter | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01049-1 |
| mdprc 050 08 16 000 | bioMerieux Inc | BK Virus R-gene Real-time Detection and Quantification Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01041-1 |
| mdprc 048 08 16 000 | Siemens Healthcare Diagnostics GmbH | Prostate-specific antigen (PSA) Assay performed on ADVIA Centaur, Centaur XP, Centaur XPT, and Centaur CP Analysers. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01005-1 |
| mdprc 031 02 16 001 | Covidien LLC | Puritan Bennett 980 Series Ventilator System PB980 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00089-1 |
| mdprc 013 08 16 000 | SIEMENS | AXIOM Artis, Artis zee and Artis Q/Q.zen system | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01004-1 |
| mdprc 012 08 16 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products Estradiol Reagent Pack | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00982-1 |
| mdprc 056 12 15 001 | Abbott Vascular Devices Div Abbott Laboratories Inc | Absorb Bioresorbable Vascular Scaffold (BVS) System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01188-1 |
| mdprc 174 07 16 000 | Abacus ALS Pty Ltd | ImmunoCAP Specific IgE Control H | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00978-1 |
| mdprc 173 07 16 000 | DePuySynthes | Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00979-1 |
| mdprc 172 07 16 000 | In Vitro Technologies | Steelco Washer Disinfectors | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00909-1 |
| mdprc 171 07 16 000 | MAQUET Inc | Maquet Operating Table with Headrest Fixture 1002.65AO | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00984-1 |
| mdprc 170 07 16 000 | Medline Industries Inc | Medline Procedure Packs containing ConvaTec Unomedical Brand Frazier Suction Handle | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00971-1 |
| mdprc 169 07 16 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00983-1 |
| mdprc 168 07 16 000 | Smith & Nephew | Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00980-1 |
| mdprc 137 07 16 000 | Siemens Healthcare Diagnostics GmbH | SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast agent injectors | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00950-1 |
| mdprc 136 07 16 000 | Philips Healthcare | MultiDiagnost Eleva and MultDiagnost Eleva with Flat Detector | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00943-1 |
| mdprc 135 07 16 000 | LivaNova PLC | Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00886-1 |
| mdprc 134 07 16 000 | DiaSorin Inc | LIAISON Estradiol II Gen Assay | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00942-1 |
| mdprc 133 07 16 000 | ConvaTec | Frazier Suction instrument | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00923-1 |
| mdprc 100 07 16 000 | Sunrise Medical | Quickie Q7 Manual Wheelchair | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00892-1 |
| mdprc 099 07 16 000 | Stryker Orthopaedics | Triathlon Modular Handles | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00910-1 |
| mdprc 098 07 16 000 | Siemens Medical Solutions | Artis systems with 19" Live Display | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00924-1 |
| mdprc 097 07 16 000 | Rex Bionics Australia Pty | REX Rehab and REX P Devices | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00852-1 |
| mdprc 096 07 16 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products HBsAg Controls | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00874-1 |
| mdprc 095 07 16 000 | Merge Healthcare Corp. | Merge CADstream, All versions | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00866-1 |
| mdprc 094 07 16 000 | Merge Healthcare Corp. | Picture Archiving and Communications Systems . | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00872-1 |
| mdprc 093 07 16 000 | Medline International Two Australia Pty Ltd | General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE Suction Irrigation Handpiece | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00882-1 |
| mdprc 092 07 16 000 | Covidien LLC | Covidien Valleylab Laparoscopic Wire Retractable Electrode | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00922-1 |
| mdprc 091 07 16 000 | Beckman Coulter, Inc.. | UniCel DxC Synchron Systems No Foam Reagent | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00900-1 |
| mdprc 090 07 16 000 | Baxter Healthcare | VASCU-GUARD Peripheral Vascular Patches | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00879-1 |
| mdprc 089 07 16 000 | B Braun Surgical SA | Safil Quick | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00855-1 |
| mdprc 052 07 16 000 | Zimmer inc | Torque Limiting Adapter for use in orthopaedic and trauma surgical procedures | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00856-1 |
| mdprc 051 07 16 000 | Roche Diagnostics Ltd | cobas 6800 system - cobas MPX, 96 tests and cobas MPX, 480 tests | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00833-1 |
| mdprc 050 07 16 000 | Merge Healthcare Corp. | iConnect Enterprise Archives | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00873-1 |
| mdprc 049 07 16 000 | Merge Healthcare Corp. | Cardio Information Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00871-1 |
| mdprc 048 07 16 000 | Merge Healthcare Corp. | Picture Archiving and Communications Systems .. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00870-1 |
| mdprc 047 07 16 000 | Merge Healthcare Corp. | CADstream MRI Systems Used with GE Phased Array Uniformity Enhancement | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00868-1 |
| mdprc 046 07 16 000 | Merge Healthcare Corp. | iConnect Enterprise Archives with Tier 2 Storage | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00864-1 |
| mdprc 045 07 16 000 | Iona Medical ProductsIona Medical Products | Volker LTC bed | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00835-1 |
| mdprc 044 07 16 000 | Emergo Asia Pacific Pty Ltd T/a Emergo Australia | Merge iConnect Enterprise Archive (iCEA) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00860-1 |
| mdprc 043 07 16 000 | Emergo Asia Pacific Pty Ltd T/a Emergo Australia | Merge PACS with software versions V6.0.2.0 MR2 and earlier | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00862-1 |
| mdprc 042 07 16 000 | Emergo Asia Pacific Pty Ltd T/a Emergo Australia | Merge PACS | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00861-1 |
| mdprc 041 07 16 000 | Emergo Asia Pacific Pty Ltd T/a Emergo Australia | Merge OrthoCase | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00869-1 |
| mdprc 040 07 16 000 | Emergo Asia Pacific Pty Ltd T/a Emergo Australia | Merge PACS | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00863-1 |
| mdprc 125 06 16 000 | Stryker Howmedica Osteonics Corp | Trident Constrained Liner Impactor Tips | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00808-1 |
| mdprc 124 06 16 000 | Sirona Dental Systems GmbH…. | Sirona Dac Universal Combination Steriliser | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00771-1 |
| mdprc 123 06 16 001 | Siemens Healthcare Diagnostics Inc | Dimension Vista Creatinine (CRE2) Flex reagent cartridge | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00807-1 |
| mdprc 122 06 16 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Centaur XPT System - Waste Reservoir Assembly | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00837-1 |
| mdprc 121 06 16 000 | QIAGEN Ltd | QIAsymphony DSP DNA Mini Kits | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00814-1 |
| mdprc 120 06 16 000 | MAQUET Inc | SERVO-i/s ventilator systems with software version 8.00.00 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00782-1 |
| mdprc 119 06 16 000 | Integra NeuroSciences | ACHILLON Minimally Invasive Achilles Tendon Suture System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00825-1 |
| mdprc 118 06 16 000 | Imaxeon Pty Ltd | Medrad MRXperion MR Injection System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00828-1 |
| mdprc 117 06 16 000 | Elekta Business Area Software Systems IMPAC Medical Systems Inc. | MOSAIQ 2.62 and higher with the IQ Scripts license enabled | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00781-1 |
| mdprc 116 06 16 000 | Draeger Medical Systems Inc | Dräger Babytherm Infant Warmer | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00794-1 |
| mdprc 115 06 16 000 | DePuySynthes | Prodisc-C Vivo Cervical Disc Implant | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00849-1 |
| mdprc 113 06 16 000 | Boston Scientific | Xenform Soft Tissue Repair Matrix 8cm x 12cm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00823-1 |
| mdprc 112 06 16 000 | Baxter Corp Canada | Softpac C299 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00815-1 |
| mdprc 097 06 16 000 | Amplitude GmbH | Score Extension Stem for Total Knee Prosthesis - Cemented | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00706-1 |
| mdprc 096 06 16 000 | Merck Serono Limited | Maxter Catheters Entral pH Indicator Strips | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00768-1 |
| mdprc 011 06 16 001 | Draeger Medical Systems Inc | Drager Ventstar Paediatric Circuit | MHRA |
| mdprc 061 03 16 001 | Siemens Healthcare Diagnostics Inc | Blood Urea Nitrogen (BUN) Flex Reagent Cartridge | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00211-1 |
| mdprc 052 06 16 000 | RaySearch Laboratories AB | RaySearch RayStation 5 | TGA |
| mdprc 051 06 16 000 | Medtronic Inc | Activa PC, Activa SC, Activa RC, Kinetra , Soletra | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00702-1 |
| mdprc 050 06 16 000 | Hill Rom Inc | Compella Bariatric Bed System, Controllers and Air Surfaces | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00745-1 |
| mdprc 049 06 16 000 | GE Healthcare | Discovery MR750w . | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00773-1 |
| mdprc 048 06 16 000 | Carl Zeiss Meditec Inc | LumaDent Light Battery Charger | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00746-1 |
| mdprc 047 06 16 000 | Bosco Medical Australia | Sorbsan Calcium Alignate Dressings and Sorbsan Silver Calcium Alignate Dressing | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00727-1 |
| mdprc 046 06 16 000 | Stryker | Target Nano Detachable Coil | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00772-1 |
| mdprc 045 06 16 000 | Teleflex Medical | Neonate Resuscitator with Coded Airway & Filter Resuscitator Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00736-1 |
| mdprc 012 06 16 000 | Philips Healthcare | Philips Brilliance 64 and Ingenuity CT/Core/Core128 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00681-1 |
| mdprc 146 05 16 000 | Zimmer inc | Sterile-Packaged Knee Implants | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00660-1 |
| mdprc 145 05 16 000 | Stryker Instruments | Specialty Size 33mm Reduced Diameter Reaming Cutter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00659-1 |
| mdprc 144 05 16 000 | Siemens Healthcare Diagnostics GmbH | Hettich Centrifuge Bucket Model 4464-R | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00663-1 |
| mdprc 143 05 16 001 | Siemens Healthcare Diagnostics GmbH | Dimension Vista Enzyme 2 Calibrator (used on the Dimension Vista System). | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00661-1 |
| mdprc 142 05 16 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00648-1 |
| mdprc 141 05 16 000 | GE Healthcare | MSK 1.5T Extreme and Optima MR430s | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00652-1 |
| mdprc 140 05 16 000 | Elekta CMS Software | Hexapod iGUIDE 2.1, iGUIDE 2.2 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00636-1 |
| mdprc 101 05 16 000 | Volcano Corp | Volcano S5, S5i, CORE, CORE Mobile Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00602-1 |
| mdprc 100 05 16 000 | ZOLL Medical Corp | AVOXimeter System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00618-1 |
| mdprc 099 05 16 000 | Thermo Fisher | RAPID Hp StAR Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00620-1 |
| mdprc 098 05 16 000 | Siemens Healthcare Diagnostics GmbH | TnI-Ultra (Troponin) Assay, 100 and 500 tests | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00603-1 |
| mdprc 097 05 16 000 | Schell Medical | Resus-EZY Manual Resuscitator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00645-1 |
| mdprc 096 05 16 000 | Philips Healthcare | Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity CT | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00576-1 |
| mdprc 095 05 16 000 | Philips Burton | Ingenuity Core128 CT System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00597-1 |
| mdprc 094 05 16 000 | HeartWare Inc | HeartWare HVAD system | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00580-1 |
| mdprc 093 05 16 000 | Diagnostic Solutions Pty Ltd | LIFECODES HLA-C eRES SSO Typing Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00591-1 |
| mdprc 092 05 16 000 | Cordis Corporation | PRECISE RX and PRECISE PRO RX Nitinol Stent Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00625-1 |
| mdprc 091 05 16 000 | Alcon Laboratories Inc. | CENTURION Vision System Fluidics Management Packs | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00613-1 |
| mdprc 003 05 16 001 | Bard Pcripheral Vascular (BPV) | EnCor Probes | MHRA |
| mdprc 055 05 16 000 | Smith & Nephew | Birmingham Hip Product Range | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00436-1 |
| mdprc 054 05 16 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Centaur XPT Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00573-1 |
| mdprc 053 05 16 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Chemistry XPT System with software versions 1.0.3 and 1.1 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00569-1 |
| mdprc 052 05 16 000 | Leica Microsystems, Inc. | Novocastra Liquid Mouse Monoclonal Antibody Calretinin | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00563-1 |
| mdprc 051 05 16 000 | Huntleigh Healthcare | Maxi Air Blower Unit - Model 230V | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00560-1 |
| mdprc 013 05 16 000 | Emergo Asia Pacific Pty Ltd T/a Emergo Australia | G-scan Brio Magnetic Resonance System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00499-1 |
| mdprc 012 05 16 000 | GE Healthcare | GE Revolution CT Computed Tomography X-ray systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00502-1 |
| mdprc 011 05 16 000 | Carestream Health Inc Div Onex Corp | Image Suite | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00501-1 |
| mdprc 010 05 16 000 | Australasian Medical & Scientific Ltd | Essure Permanent Birth Control | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00243-1 |
| mdprc 009 05 16 000 | Alcon Laboratories Inc. | LenSx Laser System with Corneal Flap Capability | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00522-1 |
| mdprc 008 05 16 000 | AGFA Corp. | DX-D 600 Digital Radiography System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00523-1 |
| mdprc 007 05 16 000 | Trumpf Medical Systems, Inc. | iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lighting | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00458-1 |
| mdprc 006 05 16 000 | Stryker Communications | CinchLock SS Knotless Anchor with Inserter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00484-1 |
| mdprc 005 05 16 000 | MAQUET Cardiovascular LLC | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00460-1 |
| mdprc 004 05 16 000 | Cook Inc, | Beacon Tip Catheters | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00483-1 |
| mdprc 056 04 16 001 | Stryker Communications | PneumoSure XL High Flow Insufflator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144721 |
| mdprc 115 04 16 000 | Siemens Medical Solutions | Insulin-Like Growth Factor I (IGF-I) Assay | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00491-1 |
| mdprc 114 04 16 000 | Medtronic Limited | Given Imaging Bravo pH monitoring systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00477-1 |
| mdprc 113 04 16 000 | Covidien LLC | Capnostream 20p Patient Monitors - battery pack | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00485-1 |
| mdprc 112 04 16 000 | Allegra Orthopaedics Limited | PF6 Tube Assembly | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00493-1 |
| mdprc 102 04 16 000 | Philips Burton | Ingenuity Core | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00476-1 |
| mdprc 101 04 16 000 | Leica Microsystems, Inc. | Aperio eSlide Manager with ImageScope | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00468-1 |
| mdprc 100 04 16 000 | Boston Scientific Cardiac Rhythm Management Group | Lotus Valve System. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00447-1 |
| mdprc 088 04 16 000 | Siemens Medical Solutions | e.cam and all Symbia systems with foresight detectors | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00419-1 |
| mdprc 087 04 16 000 | Ortho-Clinical Diagnostics | VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00420-1 |
| mdprc 086 04 16 000 | Mizuho OSI | Mizuho General Purpose Operating Table | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00394-1 |
| mdprc 085 04 16 000 | Life Healthcare | ASC Neuro Sponges | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00433-1 |
| mdprc 084 04 16 000 | Beckman Coulter | IRISpec CA/CB/CC Control Kit and IRISpec CA/CB Control Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00437-1 |
| mdprc 083 04 16 000 | Aero Healthcare | Military Trauma & Haemorrhage Wound Dressing | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00370-1 |
| mdprc 072 04 16 000 | Siemens Healthcare Diagnostics | EZee-Nest Insert Cups used with ADVIA Centaur CP | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00389-1 |
| mdprc 071 04 16 000 | PerkinElmer Life and Analytical Sciences | LifeCycle for Prenatal Screening… | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00413-1 |
| mdprc 070 04 16 000 | Navilyst Medical | PICC Catheters Contained in Various Valve Technology Kits | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00383-1 |
| mdprc 069 04 16 000 | Lovell Surgical Supplies International Pty Ltd | Hypothermia and Hyperthermia devices | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00362-1 |
| mdprc 068 04 16 000 | Hoya Corporation | Pentax ED-3490TK Video Duodenoscope | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00238-1 |
| mdprc 067 04 16 000 | Bio-Rad Laboratories Inc | ID Anti-N and ID Anti-M/N. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00373-1 |
| mdprc 057 04 16 000 | Intelerad Medical Systems Inc.. | INTELEPACS | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00346-1 |
| mdprc 016 04 16 000 | Siemens Medical Solutions | Acuson 2000 ultrasound system | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00360-1 |
| mdprc 015 04 16 000 | Siemens Medical Solutions | Dimension Vista 500 Intelligent Lab System & Dimension Vista 1500 Intelligent Lab System. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00368-1 |
| mdprc 191 03 16 000 | Thermo Fisher Scientific Oy | Oxoid Nitrocefin (+ Reconstitution Fluid) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00323-1 |
| mdprc 190 03 16 000 | Siemens Medical Solutions | Acuson SC200 ultrasound systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00353-1 |
| mdprc 189 03 16 000 | Siemens Healthcare Diagnostics | Versant kPCR Molecular System Sample Preparation | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00327-1 |
| mdprc 188 03 16 000 | Siemens Healthcare Diagnostics GmbH | Methotrexate Assay performed on Syva Emit Methotrexate Application (DVMTX.1) for the Dimension Vista System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00332-1 |
| mdprc 187 03 16 000 | Siemens Healthcare Diagnostics GmbH | Dimension and Dimension Vista Clinical Chemistry Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00350-1 |
| mdprc 186 03 16 000 | Philips Healthcare | Allura Xper | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00274-1 |
| mdprc 185 03 16 000 | Philips Healthcare | MobileDiagnost wDR Release1 and 2 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00351-1 |
| mdprc 184 03 16 000 | Philips Healthcare | Brilliance CT and Ingenuity CT | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00340-1 |
| mdprc 183 03 16 000 | Ortho-Clinical Diagnostics | TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00352-1 |
| mdprc 182 03 16 000 | Ellex Medical Pty Ltd | Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System (2RT) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00301-1 |
| mdprc 181 03 16 000 | Boston Scientific Ltd | Fetch 2 Aspiration Catheter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00359-1 |
| mdprc 149 03 16 001 | Smith & Nephew | TOPAZ MicroDebrider Wand | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00275-1 |
| mdprc 151 03 16 000 | Stryker Neurovascular | Neuroform Atlas Stent System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00298-1 |
| mdprc 150 03 16 000 | SIEMENS | Syngo X-Workplace with software version VD10E | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00267-1 |
| mdprc 148 03 16 000 | ClaveGuard Pty Ltd | Diathermy Pencil | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00280-2 |
| mdprc 101 03 16 000 | Alcon Laboratories Inc | VERION Reference Unit (Vision Planner) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00255-1 |
| mdprc 100 03 16 000 | In Vitro Technologies | Freelite Human Kappa Integra Kit. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00231-1 |
| mdprc 099 03 16 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00279-2 |
| mdprc 068 03 16 000 | ThermoFisher Scientific Microbiology Perth | B.R.A.H.M.S Free BhCG Kryptor Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00223-1 |
| mdprc 067 03 16 000 | Siemens Healthcare Diagnostics GmbH | Dimension Vista Chemistry 3 Calibrator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00236-1 |
| mdprc 066 03 16 000 | Mckesson Medical Imaging Group | Horizon Medical Imaging products. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00226-1 |
| mdprc 065 03 16 000 | Helena Laboratories | Safe-T-Vue 6 and Safe-T-Vue10 Temperature Indicators | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00233-1 |
| mdprc 064 03 16 000 | GE Healthcare | SIGNA Pioneer MR systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00242-1 |
| mdprc 063 03 16 000 | DePuySynthes | Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00235-1 |
| mdprc 062 03 16 000 | Bard Access Systems | ARCTICGEL Pads | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00234-1 |
| mdprc 060 03 16 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products Total B-hCG II Reagent Packs & Calibrators | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00209-1 |
| mdprc 059 03 16 000 | Emergo Asia Pacific Pty Ltd T/a Emergo Australia | IntelePACS InteleViewer | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00199-1 |
| mdprc 058 03 16 000 | Covidien LLC | Covidien Emprint Percutaneous Antenna (short, standard and long) with Thermosphere Technology | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00210-1 |
| mdprc 057 03 16 000 | Abacus ALS Pty Ltd | QuikRead go wrCRP and QuikRead go wrCRP+Hb | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00203-1 |
| mdprc 056 03 16 000 | CoreMed Pty Ltd | Spiggle & Theis ENT | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00184-1 |
| mdprc 055 03 16 000 | Conceiveplease Pty Ltd | Conceiveplease One Step HCG Urine Pregnancy test | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00190-1 |
| mdprc 054 03 16 000 | Boston Scientific | Boston Scientific Urogynaecological Surgical Meshes | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00120-1 |
| mdprc 053 03 16 000 | Biomet Inc | Verso Shoulder Forked Retractor | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00206-1 |
| mdprc 052 03 16 000 | B Braun Medical Inc | Sangofix set with hand pump | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00185-1 |
| mdprc 051 03 16 000 | Arrow International Inc | ARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion Kits | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00204-1 |
| mdprc 094 01 16 001 | Resmed Limited | Astral Ventilators - ResMed Astral 100 & Astral 150 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143003 |
| mdprc 021 01 16 001 | bioMerieux Inc | API ZYM B | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142938 |
| mdprc 067 02 16 000 | Biomet Inc | DVR ePAK | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00142-1 |
| mdprc 066 02 16 000 | Imaxeon Pty Ltd | Klikfit CT Syringe with QFT and 75cm Extension tube | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00173-1 |
| mdprc 065 02 16 000 | DePuySynthes | Universal Battery Charger II (UBC II) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00175-1 |
| mdprc 064 02 16 000 | Covidien LLC | Kangaroo Polyurethane Feeding Tube | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00130-1 |
| mdprc 063 02 16 000 | Actelion Pharmaceuticals Australia Pty Ltd | Veletri Consumables Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00147-1 |
| mdprc 062 02 16 000 | Beckman Coulter | Rotor Yokes (used in Allegra X-5 Centrifuge). | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00174-1 |
| mdprc 061 02 16 000 | bioMerieux Inc | VIDAS TOXO IgM Assay | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00159-1 |
| mdprc 060 02 16 000 | CK Surgitech Pty Ltd | Sureclip and Sureclip Plus Haemostasis Clips | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00181-1 |
| mdprc 142 02 14 002 | Draeger Medical Systems Inc | Oxylog Transport Ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142495 |
| mdprc 022 01 16 001 | DePuySynthes | PFNA Nails | TGA |
| mdprc 032 02 16 000 | Bio-Rad Laboratories Inc | Anti-Jk (Jk1). | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00117-1 |
| mdprc 030 02 16 000 | GE Healthcare | Carestation 620 A1, 650 A1, and 650c A1 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00143-1 |
| mdprc 029 02 16 000 | Integra LifeSciences | PyroTitan Humeral Resurfacing Arthroplasty Shapers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00091-1 |
| mdprc 028 02 16 000 | Medtronic Inc | Terumo CVS CDI H/S Cuvette provided within the Medtronic Perfusion Tubing Pack | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00124-1 |
| mdprc 027 02 16 000 | Olympus | Model TJF-Q180V Duodenoscopes .. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00098-1 |
| mdprc 026 02 16 000 | Verathon Inc | Glidescope Titanium Single-Use Video Laryngoscope Blades | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00133-1 |
| mdprc 096 01 16 000 | Varian Medical Systems | Eclipse Treatment Planning System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00064-1 |
| mdprc 095 01 16 000 | Siemens Healthcare Diagnostics | ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00068-1 |
| mdprc 093 01 16 000 | Philips Healthcare | Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP Systems. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00066-1 |
| mdprc 092 01 16 000 | Philips Healthcare | BrightView X/XCT/XCT | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00051-1 |
| mdprc 091 01 16 000 | Mobilife Pty Ltd | Saline 0.9% in 240ml elastomeric device | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00056-1 |
| mdprc 090 01 16 000 | Leica Microsystems, Inc. | PAX-5 Bond Ready-to-Use Primary Antibody Reagents Used with Bond Polymer Refine Detection Kits | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00069-1 |
| mdprc 089 01 16 000 | Hill Rom Inc | Liko Universal SlingBar 350, SlingBar 450 and SlingBar 600 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00082-1 |
| mdprc 088 01 16 000 | Fresenius Kabi Ltd | Curlin 6000 and Painsmart IOD | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00053-1 |
| mdprc 058 01 16 001 | GE Healthcare | fluoroscopic imaging systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00003-2 |
| mdprc 063 01 16 000 | Siemens Healthcare Diagnostics Product | BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00025-2 |
| mdprc 062 01 16 000 | Murray International Trading Pty Ltd | One Step HCG Urine Pregnancy Test | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00024-2 |
| mdprc 059 01 16 000 | HeartWare Inc | HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01261-1 |
| mdprc 057 01 16 000 | Abacus ALS Pty Ltd | EliA SmDP Well | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00013-2 |
| mdprc 060 12 15 001 | Ethicon Inc | Gynecare Thermachoice III Thermal Balloon Ablation Silicone Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142341 |
| mdprc 082 05 15 001 | Resmed Limited | Astral 100, Astral 15 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00391-1 |
| mdprc 024 01 16 000 | Trumpf Medical Systems, Inc. | TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01250-1 |
| mdprc 023 01 16 000 | Stryker Communications | VariAx 2 3.5 mm screws, Included in VariAx Compression EPS system tray | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01262-1 |
| mdprc 158 12 14 001 | St. Jude Medical Inc | RF enabled St. Jude Medical Ellipse, Fortify Assura, Unify Assura, and Quadra Assura Implantable Cardioverter Defibrillators (ICDs) and Assurity and Allure Pacemakers when used with Merlin@home RF Remote Monitoring Transmitter Model EX1150 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01335-1 |
| mdprc 137 12 15 000 | SIEMENS | All Magnetom MRI systems with superconductive magnets | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01251-1 |
| mdprc 136 12 15 000 | Siemens Medical Solutions | 96 Deep Well Plate 2mL | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01257-1 |
| mdprc 135 12 15 000 | Radiometer America Inc | TCM CombiM module | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01200-1 |
| mdprc 134 12 15 000 | GE Healthcare | All Giraffe Carestation Beds | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01233-1 |
| mdprc 133 12 15 000 | C R Bard Inc | 2-Way Foley Catheters and 2-Way Council Tip Foley Catheters | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01254-1 |
| mdprc 132 12 15 000 | Bio Rad. | Dengue NS1 Ag Strip | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01238-1 |
| mdprc 131 12 15 000 | Becton Dickinson & Co. (BD) | BD Vacutainer Heparin Tube. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01249-1 |
| mdprc 130 12 15 000 | Accriva Diagnostics | VerifyNow Aspirin Test Kits Used with VerifyNow Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01252-1 |
| mdprc 087 12 15 001 | Device Technologies Australia Pty Ltd | Arcadophta SARL | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01229-1 |
| mdprc 102 12 15 000 | Ambu Inc | AuraGain Disposable Laryngeal Masks | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01240-1 |
| mdprc 101 12 15 000 | Philips Healthcare | IntelliVie Information Centre (PIIC) iX | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01226-1 |
| mdprc 004 12 15 001 | ConvaTec | Nebulisers / Nebuliser Mask Products | MHRA |
| mdprc 076 12 15 000 | DePuySynthes | PFN/PFNA Insertion Handle | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01211-1 |
| mdprc 064 12 15 000 | Elekta CMS Software | MOSAIQ version 2.5 and above - Medical Oncology only | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01216-1 |
| mdprc 063 12 15 000 | Biomet 3i Inc | Multiple dental abutment products and their accessories. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01208-1 |
| mdprc 062 12 15 000 | Beckman Coulter | Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01204-1 |
| mdprc 061 12 15 000 | Leica Microsystems Inc. | Bond Polymer Refine Red Detection Kits | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01206-1 |
| mdprc 059 12 15 000 | Diagnostic Solutions Pty Ltd | ENA RELISA Single Well Screen (576 well) Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01194-1 |
| mdprc 058 12 15 000 | Boston Scientific | ACUITY Pro 9 Fr Guide Catheter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01192-1 |
| mdprc 057 12 15 000 | Bayer Healthcare LLC | Bayer Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01195-1 |
| mdprc 011 12 15 001 | bioMerieux Inc | Etest PIPTAZO PTC 256 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01171-1 |
| mdprc 126 11 15 001 | Siemens Medical Solutions | ADVIA Centaur and ADVIA Centaur XP.. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01135-1 |
| mdprc 110 11 15 001 | Siemens Medical Solutions | Dimension Integrated Chemistry Systems. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01114-1 |
| mdprc 015 12 15 000 | Biomet Inc | A.L.P.S. Cancellous Locking Screws | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01162-1 |
| mdprc 014 12 15 000 | Siemens Medical Solutions | syngo X-Workplace with software VD10E and tabcard ”4D” | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01151-1 |
| mdprc 013 12 15 000 | KCI USA Inc | 300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01169-1 |
| mdprc 012 12 15 000 | Kawasumi Laboratories Inc | MediRedi A.V. Fistula Pack | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01168-1 |
| mdprc 003 12 15 000 | Brainlab AG | Brainlab Brain Metastases Adaptive Hybrid Surgery Analysis | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01164-1 |
| mdprc 002 12 15 000 | Independent Home Care & Surgical Supplies Pty Ltd | Karma Wheelchairs | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01157-1 |
| mdprc 001 12 15 000 | bioCSL Pty Ltd | Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01146-1 |
| mdprc 127 11 15 000 | Terumo BCT Inc | A.V. Fistula sets for Haemodialysis - Safety AVF Needle fixed wing | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01147-1 |
| mdprc 125 11 15 000 | Siemens Medical Solutions | Artis systems with large display module | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01109-1 |
| mdprc 106 09 15 001 | Roche Diagnostics Corp | Bulk Loader Module (BLM) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141086 |
| mdprc 109 11 15 000 | QIAGEN Ltd | artus C. trachomatis Plus kits | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01117-1 |
| mdprc 108 11 15 000 | Beckman Coulter Inc | AU480, AU680, AU5800 Chemistry Analysers. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01044-1 |
| mdprc 107 11 15 000 | Bard Pcripheral Vascular (BPV) | ARCTIC SUN 5000 Temperature Management Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01116-1 |
| mdprc 070 11 15 001 | LeMaitre Vascular GmbH | LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm | BfArM |
| mdprc 094 11 15 000 | Ortho-Clinical Diagnostics | VITROS 3600 and 5600 Systems using Software Version 3.2 and Below | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01098-1 |
| mdprc 093 11 15 000 | Implant Direct LLC | DGDE DirectGuideTM Drill Extender and kits containing the DGDE Drill Extender | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01091-1 |
| mdprc 092 11 15 000 | Device Technologies Australia Pty Ltd | Arceole C3F8 and SF6 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01106-1 |
| mdprc 072 11 15 000 | Philips Burton | Philips MX 16-slice Computer tomography x-ray system | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01082-1 |
| mdprc 071 11 15 000 | Masimo Corp | Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01074-1 |
| mdprc 069 11 15 000 | CareFusion 206 Inc, | Alaris System Syringe Module | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01080-1 |
| mdprc 068 11 15 000 | Becton Dickinson & Co. (BD) | Ultra-Fine Insulin Syringe for use with U-100 insulin | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01055-1 |
| mdprc 067 11 15 000 | Beckman Coulter | ichem VELOCITY Urine Chemistry Strips .. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01092-1 |
| mdprc 047 11 15 000 | Prius Healthcare Solutions Pty Ltd | Prius Elite Bed | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01060-1 |
| mdprc 046 11 15 000 | Carl Zeiss Meditec Inc | IOLMaster 500 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01065-1 |
| mdprc 045 11 15 000 | Baxter Healthcare | Vented Paclitaxel Set | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01070-1 |
| mdprc 013 11 15 001 | Medtronic Inc | Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) | MHRA |
| mdprc 026 11 15 000 | Siemens Medical Solutions | SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral" | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01057-1 |
| mdprc 025 11 15 000 | Beckman Coulter | Access free T3 Reagent kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01042-1 |
| mdprc 014 11 15 000 | GE Healthcare | Revolution CT Scanners | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01058-1 |
| mdprc 012 11 15 000 | Physio Control Inc | LifePack 1000 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01036-1 |
| mdprc 011 11 15 000 | Roche Diagnostics Corp | BenchMark ULTRA & DISCOVERY ULTRA | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01032-1 |
| mdprc 010 11 15 000 | Beckman Coulter | Access CEA Reagent Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01035-1 |
| mdprc 009 11 15 000 | Elekta Inc | MONACO system | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01023-1 |
| mdprc 008 11 15 000 | Thermo Fisher Scientific Oy | Quidel Sofia Legionella FIA. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01034-1 |
| mdprc 087 10 15 000 | Orthotech Pty Ltd | Vaios Total Shoulder Replacement System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00976-1 |
| mdprc 086 10 15 000 | Beckman Coulter Inc | AU480 Clinical Chemistry Analyser | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01011-1 |
| mdprc 059 10 15 000 | Dickson & Dickson Healthcare | OLS-500 & OLS-700 surgical lights | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00989-1 |
| mdprc 058 10 15 000 | Philips Healthcare | Allura Xper FD X-Ray Systems ... | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00995-1 |
| mdprc 057 10 15 000 | Olympus Winter & IBE GmbH | Disposable Myringotomy blade with handle | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01002-1 |
| mdprc 056 10 15 000 | Hospira Inc | Plum 360 Infusion Pump | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00986-1 |
| mdprc 028 10 15 000 | Stryker Howmedica Osteonics Corp | Duracon Augments | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00971-1 |
| mdprc 027 10 15 000 | Ethicon Inc A Johnson & Johnson Co | Ethicon HARMONIC ACE+ 7 Laparoscopic Shears | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00994-1 |
| mdprc 023 10 15 000 | Stryker Instruments. | Exeter Small and Large Tapered Pin Reamer | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00972-1 |
| mdprc 022 10 15 000 | Stryker Howmedica Osteonics Corp | PCA Tapers, LFIT V40 Tapers, V40 Tapers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00922-1 |
| mdprc 021 10 15 000 | Rehab Assist Pty Ltd | Prism Medical P300 and C300 Ceiling Hoist | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00967-1 |
| mdprc 019 10 15 000 | Medtronic Diabetes | MiniMed 640G insulin pump | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00968-1 |
| mdprc 018 10 15 000 | GE Healthcare | Giraffe Shuttle Products | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00927-1 |
| mdprc 006 10 15 000 | Allergan Medical SA | REFRESH NIGHT TIME and Ircal Eye Ointments | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00809-1 |
| mdprc 135 09 15 000 | Siemens Healthcare Diagnostics | Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00961-1 |
| mdprc 134 09 15 000 | DePuySynthes | Specialist 2 Intramedullary Rod 400 mm Instruments | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00956-1 |
| mdprc 125 09 15 000 | Neoss Australia Pty Ltd | Neoss Guide | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00917-1 |
| mdprc 124 09 15 000 | Medtronic Inc | Medtronic Navigated Solera Driver Tips for Spinal Surgery | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00925-1 |
| mdprc 123 09 15 000 | DePuySynthes | Sciatic Nerve Retractors | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00938-1 |
| mdprc 122 09 15 000 | Alba Bioscience | Anti-Leb ALBAclone | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00898-1 |
| mdprc 108 09 15 000 | Xcel Medical Solutions Pty Ltd | Suction Adapter Type A (Gauge) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00929-1 |
| mdprc 107 09 15 000 | Teleflex Medical.. | 4FR Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00915-1 |
| mdprc 105 09 15 000 | Mathys Ltd Bettlach | seleXys TH+ and seleXys TPS acetabular shells | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00770-1 |
| mdprc 104 09 15 000 | Elekta Inc | Monaco. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00910-1 |
| mdprc 085 09 15 000 | Leica Biosystems Newcastle Ltd | Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00892-1 |
| mdprc 076 09 15 000 | Stryker Instruments | Base array component of the MAKO RIO Robotic Arm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00873-1 |
| mdprc 075 09 15 000 | Olympus | GF-UCT180 Ultrasonic Gastrovideoscope | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00909-1 |
| mdprc 074 09 15 000 | Huntleigh Healthcare. | Maxi Air Blower Unit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00859-1 |
| mdprc 073 09 15 000 | William C. Domb, D.M.D | CA1:1L EVO 15 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00840-1 |
| mdprc 041 09 15 001 | Stryker Communications | ALIQUOT Delivery System Complete Set | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00843-1 |
| mdprc 016 09 15 001 | Baxter Healthcare | Actifuse ABX and Actifuse MIS System | MHRA |
| mdprc 044 09 15 000 | Terumo BCT Inc | Spectra Optia Apheresis System. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00862-1 |
| mdprc 043 09 15 000 | Medtronic.. | CryoConsole Models | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00853-1 |
| mdprc 042 09 15 000 | IRIS Diagnostics | iChem Velocity Urine Chemistry Strips. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00806-1 |
| mdprc 040 09 15 000 | Ethicon Inc | GYNEMESH PS & TVT Devices | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00743-1 |
| mdprc 039 09 15 000 | Coloplast A/S | Coloplast urogynaecological surgical mesh, Aris Kit, Altis System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00748-1 |
| mdprc 038 09 15 000 | Becton Dickinson & Co. (BD) | BD Affirm VPIII Microbial Identification Tests | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00844-1 |
| mdprc 019 09 15 000 | Edwards Lifesciences | Edwards Pressure Monitoring Kit & Set | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00772-1 |
| mdprc 018 09 15 000 | Covidien LLC | Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connect | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00803-1 |
| mdprc 017 09 15 000 | Bayer Healthcare LLC | CONTOUR NEXT control solutions | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00746-1 |
| mdprc 086 02 15 001 | Roche Diagnostics Ltd | Elecsys CMV IgM assay (04784618190) - Diluent Universal. | Swissmedic |
| mdprc 191 08 15 000 | Alcon Laboratories Inc | LX3 Microscope Floor Stand used with the LuxOR Ophthalmic Microscope and LuxOR Ophthalmic Microscope with Q-VUE 3D Assistant Visualisation | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00757-1 |
| mdprc 166 08 15 000 | St. Jude Medical Inc | RF enabled St. Jude Medical Ellipse, Fortify Assura, Unify Assura, and Quadra Assura Implantable Cardioverter Defibrillators (ICDs) and Assurity and Allure Pacemakers when used with Merlin@home RF Remote Monitoring Transmitter Model EX1150 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00756-1 |
| mdprc 165 08 15 000 | Philips Burton | Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00755-1 |
| mdprc 164 08 15 000 | BMDi TUTA Healthcare Pty Ltd | Extension Set | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00719-1 |
| mdprc 144 08 15 000 | Abbott Diabetes Care Div Abbott Laboratories Inc | FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00672-1 |
| mdprc 107 08 15 000 | Siemens Medical Solutions | Artis Q and Q.zen Floorstand and ArtisQ and Q.zen Biplane Floorstand systems with SW version VD10E | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00626-1 |
| mdprc 106 08 15 000 | PerkinElmer Life and Analytical Sciences | DELFIA Xpress PlGF Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00629-1 |
| mdprc 105 08 15 000 | GE Healthcare | MR ACGD Cabinet FRU X Gradient Cable used with GE MRI System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00675-1 |
| mdprc 104 08 15 000 | Philips Burton | Siesta i TS machine | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00707-1 |
| mdprc 102 08 15 000 | Molnlycke Health Care AB | Waratah Private General Packs and Waratah Private Knee/Shoulder Arthro Pack | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00712-1 |
| mdprc 101 08 15 000 | Leica Microsystems Inc. | Leica ASP200S & Leica ASP300S. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00717-1 |
| mdprc 100 08 15 000 | Intelerad Medical Systems Inc. | IntelePACS software versions from 4.5.1 to 4.11.1. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00705-1 |
| mdprc 099 08 15 000 | DePuySynthes | DePuy Synthes Socket, Hexagonal Ø 4.0mm/11.0mm. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00723-1 |
| mdprc 098 08 15 000 | Becton Dickinson & Co. (BD) | BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 21G & 22G. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00728-1 |
| mdprc 097 08 15 000 | Beckman Coulter Inc | UniCel DxC ISE Reference reagent tubing | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00697-1 |
| mdprc 016 07 15 001 | Stryker Instruments | Stryker Sterile Implants | BfArM |
| mdprc 066 08 15 000 | Unomedical A/S | Neria Infusion Administration Set | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00536-1 |
| mdprc 065 08 15 000 | Smith & Nephew inc | Sureshot Humeral 3.2mm AO Drill | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00689-1 |
| mdprc 064 08 15 000 | SIEMENS | Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ option | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00595-1 |
| mdprc 063 08 15 000 | Siemens Medical Solutions | ACUSON S Family Ultrasound Systems utilising the 18L6 HD and/or 6C1 HD biopsy guidelines | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00609-1 |
| mdprc 062 08 15 000 | SIEMENS | Artis systems with SW version VC14J | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00612-1 |
| mdprc 061 08 15 000 | Radiometer Medical | MicroGas 7650 Operator Manual used with Radiometer MicroGas 7650 Transcutaneous Monitor | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00617-1 |
| mdprc 060 08 15 000 | Ortho-Clinical Diagnostics | VITROS 5,1 FS System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00607-1 |
| mdprc 059 08 15 000 | ITL Healthcare | Back Table Cover supplied in a limited range of Operating Room Packs | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00686-1 |
| mdprc 058 08 15 000 | Elekta CMS Software | MOSAIQ Release 2.41 and higher | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00608-1 |
| mdprc 121 06 15 001 | bioMerieux Inc | CEFOTAXIME CT 256 WW F100. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00516-1 |
| mdprc 020 07 15 000 | Trumpf Medical Systems, Inc. | Ceiling Supply Unit klinoPORT | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00590-1 |
| mdprc 019 07 15 000 | Siemens Medical Solutions | ADVIA Chemistry Systems - Acetaminophen N-acetylcysteine (NAC) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00598-1 |
| mdprc 018 07 15 000 | Philips Burton | SENSE Body Coil 1.5T Used with ACS NT, Achieva 1.5T, and Intera 1.5T Magnetic Resonance Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00584-1 |
| mdprc 017 07 15 000 | Philips Burton | Philips HeartStart XL+ | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00588-1 |
| mdprc 015 07 15 000 | Philips Healthcare | Masimo uSpO2 and HPLP Oximetry Cables | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00542-1 |
| mdprc 014 07 15 000 | bioMerieux Inc | Parechovirus r-gene | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00579-1 |
| mdprc 013 07 15 000 | Abbott Laboratories Inc | i-STAT PT/INR Cartridges | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00549-1 |
| mdprc 009 07 15 000 | Koala Medical Pty Ltd | Paediatric Anaesthetic Breathing Circuit with Swivel Wye | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00552-1 |
| mdprc 008 07 15 000 | AMS USA | Reusable Stripper and Cleaver Accessories Used with Aura Fibers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00570-1 |
| mdprc 155 06 15 000 | ConvaTec | Suction Tube | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00514-1 |
| mdprc 154 06 15 000 | Topcon | TOPCON – 3D Optical Coherence Tomography 3D OCT-1 MAESTRO machines | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00517-1 |
| mdprc 153 06 15 000 | Cook Medical | Lunderquist Extra-Stiff Wire Guide | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00545-1 |
| mdprc 152 06 15 000 | Argon Medical Devices Inc | ARGON Bone Marrow I-type aspirate/biopsy needles & ARGON Trap-Lok Bone Marrow biopsy needles | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00541-1 |
| mdprc 122 06 15 000 | SIEMENS | Immulite (all systems), Sample Cup Holders and Microsample Inserts. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00520-1 |
| mdprc 120 06 15 000 | Beckman Coulter | Access 2 Immunoassay Systems. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00488-1 |
| mdprc 098 06 15 000 | Roche Diagnostics Corp | Tina-quant Soluble Transferrin Receptor (STFR): Elevated imprecision with QC Level 1 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00499-1 |
| mdprc 097 06 15 000 | Philips Healthcare | Ultrasound Q-Station | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00491-1 |
| mdprc 096 06 15 000 | NDI | Disposable Reflective Marker Spheres | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00502-1 |
| mdprc 073 06 15 000 | Verathon Inc | GlideScope Reusable Video Laryngoscope Blades | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00461-1 |
| mdprc 072 06 15 000 | Siemens Medical Solutions | Artis zee Floorstand, Artis zee Biplane Floorstand and Artis zee Multi Purpose systems with SW version VC21B | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00483-1 |
| mdprc 071 06 15 000 | Roche Diagnostics Corp | Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) reaction | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00463-1 |
| mdprc 070 06 15 000 | Ortho-Clinical Diagnostics | VITROS Performance Verifier I for unconjugated bilirubin (Bu) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00465-1 |
| mdprc 069 06 15 000 | Bausch & Lomb Contact Lenses | SofPort Advanced Optics Aspheric IOL, Model LI61AO | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00477-1 |
| mdprc 068 06 15 000 | Bard Access Systems | Bard Per-Q-Cath line of products | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00480-1 |
| mdprc 035 06 15 000 | Smiths Medical ASD Inc.. | CADD- Solis Ambulatory Infusion Pumps | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00447-1 |
| mdprc 034 06 15 000 | Varian Medical Systems | Surface Applicator Set with Leipzig-style Cone | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00446-1 |
| mdprc 033 06 15 000 | Siemens Medical Solutions | ADVIA Centaur TnI-Ultra | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00442-1 |
| mdprc 032 06 15 000 | Siemens Medical Solutions | syngo Workflow SLR with versions VA31, VA32, VB10, or VB20A (TBC) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00443-1 |
| mdprc 013 06 15 000 | SIEMENS | Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i and CS-5100 instruments | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00426-1 |
| mdprc 012 06 15 000 | Siemens Healthcare Diagnostics GmbH | Dimension Vista 500 and 1500 Intelligent Lab System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00430-1 |
| mdprc 011 06 15 000 | Philips Burton | FlexTEMP Temperature Sensors Used with Expression MRI Patient Monitoring Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00425-1 |
| mdprc 010 06 15 000 | PerkinElmer Life and Analytical Sciences | WIZARD2 Gamma Counters | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00417-1 |
| mdprc 009 06 15 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products NT-proBNP Calibrators and Reagent Packs | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00427-1 |
| mdprc 008 06 15 000 | OMNIlife science | Apex 10mm reamer | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00419-1 |
| mdprc 140 05 15 000 | Animas Corporation . | Animas 2020 and Animas IR 1200 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00363-1 |
| mdprc 139 05 15 000 | Medtronic Inc | Various Shiley Tracheostomy Tubes | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00412-1 |
| mdprc 138 05 15 000 | Device Technologies Australia Pty Ltd | Microtek Medical System Drapes used with da Vinci, da Vinci Si, da Vinci Si/S Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00351-1 |
| mdprc 137 05 15 000 | Emergo Asia Pacific Pty Ltd T/a Emergo Australia | IntelePACS | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00404-1 |
| mdprc 136 05 15 000 | Philips Healthcare | Philips Model AFFINITI 70 Ultrasound System without Pediatric Cardiology option | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00409-1 |
| mdprc 135 05 15 000 | SIEMENS | Immulite 2000 and Immulite 2000 XPi – Italian Cypress Allergen | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00401-1 |
| mdprc 134 05 15 000 | SIEMENS | Cios Alpha mobile C-arm x-ray system | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00399-1 |
| mdprc 133 05 15 000 | Siemens Healthcare Diagnostics | RAPIDLab Blood Gas Analyzers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00416-1 |
| mdprc 079 05 15 001 | HeartWare Inc | HeartWare HVAD System .. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00370-1 |
| mdprc 081 05 15 000 | Olympus | Diego Elite Tubesets | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00397-1 |
| mdprc 080 05 15 000 | Medline Industries Inc | Medline Procedure Packs containing Covidien Devon Light Gloves | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00395-1 |
| mdprc 078 05 15 000 | Device Technologies Australia Pty Ltd | Corpatch Easy Paediatric | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00388-1 |
| mdprc 077 05 15 000 | Thermo Fisher Scientific Inc. | Remel PathoDx Strep B Group Latex | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00380-1 |
| mdprc 049 06 14 001 | SIEMENS | ARTISTE, ONCOR and PRIMUS with Automatic Sequenced Treatment Delivery Option | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00614-1 |
| mdprc 039 05 15 000 | Helena Laboratories | OPTI Blood Gas analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00367-1 |
| mdprc 024 05 15 000 | Covidien | Devon Light Gloves | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00364-1 |
| mdprc 023 05 15 000 | Invacare Corporation | Invacare TDX series and Storm Series power wheelchairs | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00356-1 |
| mdprc 146 04 15 000 | SIEMENS | Dimension Vista Systems LOCI Thyroid Stimulating Hormone. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00357-1 |
| mdprc 145 04 15 000 | SonoSite Inc | SonoSitePowerPark Dock and Stand Module(s) used with SonoSite Ultrasound Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00305-1 |
| mdprc 122 04 15 000 | Siemens Medical Solutions | Amylase Assay used with ADVIA Chemistry Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00340-1 |
| mdprc 121 04 15 000 | Groupon Australia Pty Ltd | Counterfeit Durex branded condoms purchased from Groupon website | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00346-1 |
| mdprc 120 04 15 000 | Fisher & Paykel Healthcare Limited | Harris Oxygen Flowmeter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00266-1 |
| mdprc 095 04 15 000 | Baxter Healthcare | Baxter Irrigation solutions | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00329-1 |
| mdprc 094 04 15 000 | Bio-Rad Laboratories Inc | ID-LISS/Coombs Cards. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00314-1 |
| mdprc 093 04 15 000 | Device Technologies Australia Pty Ltd | STERIS Caviwave Pro Ultrasonic Cleaning System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00323-1 |
| mdprc 092 04 15 000 | ELITech Group SAS | Dako Beta-2-Microglobulin PET Kits. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00331-1 |
| mdprc 091 04 15 000 | Karl Storz GmbH & Co KG | Karl Storz Tissue Morcellation System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00310-1 |
| mdprc 090 04 15 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Systems. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00326-1 |
| mdprc 089 04 15 000 | Ortho-Clinical Diagnostics | enGen Laboratory Automation Systems .. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00328-1 |
| mdprc 088 04 15 000 | Specsavers Pty Ltd | Easyvision Umere Daily Contact Lenses (-6.50) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00303-1 |
| mdprc 060 04 15 000 | Solaris Medical Technology | Aegis Standing Sling | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00308-1 |
| mdprc 049 07 14 001 | PerkinElmer Life and Analytical Sciences | Panthera-Puncher 9 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00714-1 |
| mdprc 038 04 15 000 | CareFusion | Alaris PC units | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00289-1 |
| mdprc 037 04 15 000 | DePuySynthes | Cross-Link Clamp for Rods, 6.0 mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00290-1 |
| mdprc 007 04 15 000 | Stryker Instruments | CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00284-1 |
| mdprc 006 04 15 000 | Radiometer Medical | Radiometer immunoassay AQT90FLEX Analyser | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00273-1 |
| mdprc 005 04 15 000 | K Care Pty Ltd | My Mobility Walking Frame with Front Wheels | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00277-1 |
| mdprc 004 04 15 000 | Covidien LLC | Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00267-1 |
| mdprc 003 04 15 000 | Bard | CONQUEST PTA Dilatation Catheters | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00286-1 |
| mdprc 002 04 15 000 | Alere International Limited | Captia Malaria EIA | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00275-1 |
| mdprc 013 03 15 001 | Becton Dickinson & Co. (BD) | BD Q-Syte Luer Access Split Septum Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134096 |
| mdprc 121 03 15 000 | Transonic Systems Inc | Transonic Hemodialysis Monitor | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00183-1 |
| mdprc 120 03 15 000 | RQSolutions Medical Devices Distribution Support | METAL SHELL, CEM.LESS ‘DeltaLox’ SCREW FIX., TiNb-COAT | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00210-1 |
| mdprc 119 03 15 000 | Roche Diagnostics Corp | Cobas c 501 / c 502 and COBAS INTEGRA | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00229-1 |
| mdprc 118 03 15 000 | Philips Healthcare | Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity Elite and Ingenuity CT | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00212-1 |
| mdprc 117 03 15 000 | GE Healthcare | Model T2100 Treadmills | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00259-1 |
| mdprc 116 03 15 000 | Diversey Australia Pty Ltd | Divercleanse 750ml | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00262-1 |
| mdprc 115 03 15 000 | AngioDynamics | Morpheus Smart CT PICC Kits | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00263-1 |
| mdprc 114 03 15 000 | AMO Manufacturing | Catalys Precision Laser System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00240-1 |
| mdprc 150 12 13 001 | Fresenius Kabi Ltd | CompoStop Flex 3F T&B - 100/600/1300 - PLT Pooling - | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01329-1 |
| mdprc 085 03 15 000 | Siemens Healthcare Diagnostics | IMMULITE 2000/IMMULITE 2000 Xpi | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00201-1 |
| mdprc 084 03 15 000 | Ortho-Clinical Diagnostics | VITROS 5,1 FS Chemistry Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00214-1 |
| mdprc 083 03 15 000 | Getinge Disinfection | Getinge 46 Series | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00174-1 |
| mdprc 082 03 15 000 | BrainLAB | EXACTRAC 6.x | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00204-1 |
| mdprc 059 04 14 001 | GE Healthcare | Kenex suspension arm with radiation shield and/or surgical lamp | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00407-1 |
| mdprc 044 03 15 000 | Whiteley Corporation Pty Ltd | Sonidet – Medical Equipment & Instrument Detergent | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00186-1 |
| mdprc 043 03 15 000 | Edwards Lifesciences | Edwards Lifesciences Heart Reference Sensor ( HRS) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00162-1 |
| mdprc 100 02 15 001 | Philips Burton | Allura Xper R7.2.x | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00122-1 |
| mdprc 021 03 15 000 | Kerr Corp | Cure Sleeve | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00173-1 |
| mdprc 020 03 15 000 | Defries Industries Pty Ltd | PVC TUBING X-RAY | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00170-1 |
| mdprc 015 03 15 000 | Stryker Orthopaedics | Triathlon Distal Capture Assemblies | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00140-1 |
| mdprc 014 03 15 000 | Stryker Orthopaedics | LFIT V40 Femoral Heads | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00129-1 |
| mdprc 121 02 15 000 | Siemens Healthcare Diagnostics Product | IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive Bias | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00131-1 |
| mdprc 111 02 15 000 | GRC Surgical Pty Ltd | LiNA Xcise Laparoscopic Morcellator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00119-1 |
| mdprc 110 02 15 000 | GE Healthcare | T2100 and T2000 Treadmill power cords | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00128-1 |
| mdprc 155 12 14 001 | Radiometer America Inc | Radiometer ABL90Flex analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00124-1 |
| mdprc 099 02 15 000 | Medicina | Medicina Orange Enteral Feeding Pump | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00125-1 |
| mdprc 098 02 15 000 | Australian Orthotic Technologies Pty Ltd | Airlight ROM brace | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00090-1 |
| mdprc 089 02 15 000 | Endocorp Pty Ltd | Morce Power Plus 2307 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00107-1 |
| mdprc 088 02 15 000 | Thermo Fisher Scientific Microbiology Perth inc | Oxoid Antimicrobial Susceptibility Testing Discs TIM85 Ticarcillin/Clavulanic Acid (CT0449B) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00094-1 |
| mdprc 085 02 15 000 | Olympus | Olympus | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00112-1 |
| mdprc 084 02 15 000 | GE Healthcare | Proteus XR/a X-ray imaging systems manufactured with wall stand | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00116-1 |
| mdprc 034 02 15 001 | Zimmer inc | Various Femoral Heads | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00029-1 |
| mdprc 055 02 15 000 | Spacelabs Healthcare Inc | qube Compact Monitor & XPREZZON Bedside Monitor | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00104-1 |
| mdprc 054 02 15 000 | Philips Medical Systems | Allura Systems: Field extensions Vascular R7.6 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00105-1 |
| mdprc 053 02 15 000 | Biomet Inc | M2a 38 Acetabular Cup, M2a 38 Femoral Head, M2a Magnum Tri-Spike Acetabular Cup & M2a Magnum Femoral Heads | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00100-1 |
| mdprc 042 02 15 000 | Philips Burton | DuraDiagnost X-ray System. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00089-1 |
| mdprc 037 02 15 000 | Roche Diagnostics Corp | Cobas EGFR MutationTest Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00091-1 |
| mdprc 036 02 15 000 | Gambro | AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machines | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00093-1 |
| mdprc 035 02 15 000 | bioMerieux Inc | VITEK 2 System version 7.01. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00096-1 |
| mdprc 033 02 15 000 | Smiths Medical ASD Inc.. | CADD Medication Cassette Reservoir, 50ml | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00081-1 |
| mdprc 032 02 15 000 | Simavita Aust Pty Ltd | SIM System with SIM dock power supply model Franmar FRA012-S05-I | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00076-1 |
| mdprc 031 02 15 000 | Siemens Healthcare Diagnostics | Siemens Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00084-1 |
| mdprc 030 02 15 000 | Siemens Healthcare Diagnostics Product | ADVIA Chemistry Systems Drug Calibrator I for Phenytoin 2 and Phenobarbital 2 Assays. An in vitro Diagnostic Medical Device. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00062-1 |
| mdprc 029 02 15 000 | Covidien LLC | Puritan Bennett 980 Series Ventilator System.. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00048-1 |
| mdprc 151 12 14 001 | Covidien LLC | Trellis 8 Peripheral Infusion System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132204 |
| mdprc 089 01 15 001 | Siemens Medical Solutions | syngo.plaza | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133015 |
| mdprc 121 01 15 000 | Carl Zeiss Meditec Inc | FORUM Software | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00051-1 |
| mdprc 112 01 15 001 | Stryker Communications | System 6 Aseptic Battery Kit | http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/43389r-eng.php |
| mdprc 152 12 14 001 | Diagnostic Solutions Pty Ltd | PF4 IgG assay (Thrombophilia and coagulation inhibitor assay) | Swissmedic |
| mdprc 095 01 15 000 | Zimmer inc | Persona TASP Shims | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00013-1 |
| mdprc 094 01 15 000 | Sony Electronics | SONY LMD-1951MD MONITORS | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00032-1 |
| mdprc 093 01 15 000 | Smiths Medical Inc | Single Limb Circuit for Pneupac Ventilators, with PEEP Valve | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00047-1 |
| mdprc 092 01 15 000 | Siemens Medical Solutions | ACUSON SC2000 ultrasound systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00035-1 |
| mdprc 091 01 15 000 | Medicina | Medicina SILOBAG | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00043-1 |
| mdprc 088 01 15 000 | Ortho-Clinical Diagnostics | Hand?held Barcode Scanner used with VTROS clinical chemistry systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00033-1 |
| mdprc 075 01 15 000 | Intrinsic Therapeutics Inc | Prosthesis, internal, spine, disc | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00002-1 |
| mdprc 094 06 14 001 | GE Healthcare | Proteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging systems | MHRA |
| mdprc 161 12 14 001 | Leica Microsystems, Inc. | NCL-L-CD15. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01357-1 |
| mdprc 160 12 14 000 | Synthes Inc | Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01366-1 |
| mdprc 159 12 14 000 | Synthes Inc | Bending/Cutting Pliers with Nose | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01359-1 |
| mdprc 157 12 14 000 | St. Jude Medical Inc | Sensei X Robotic Catheter System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01325-1 |
| mdprc 156 12 14 000 | Siemens Medical Solutions | Digital Linear Accelerators of type MEVATRON, PRIMUS, ONCOR and ARTISTE. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01358-1 |
| mdprc 154 12 14 000 | Medline International Two Australia Pty Ltd | Minor Plastics Pack IVF Australia | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01360-1 |
| mdprc 153 12 14 000 | Elekta Limited | Focal Release 4.80.00 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01356-1 |
| mdprc 150 12 14 000 | Beckman Coulter | Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase Analytes | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01350-1 |
| mdprc 052 02 14 001 | ThermoFisher Scientific Microbiology Perth | -Oxoid Legionella Latex Test
-Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00135-1 |
| mdprc 121 12 14 000 | GI Dynamics Inc | EndoBarrier Gastrointestinal Liner with Delivery System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01320-1 |
| mdprc 065 10 14 001 | Covidien LLC | Puritan Bennett 980 Series Ventilator System. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01326-1 |
| mdprc 111 12 14 000 | SIEMENS | Artis Q and Q.zen Ceiling Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01307-1 |
| mdprc 110 12 14 000 | Radiometer America Inc | AQT90Flex TnI (troponin) Test Kit. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01304-1 |
| mdprc 109 12 14 000 | BrainLAB El Seif | iPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localiser and one of the positioning solutions Target Positioner | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01293-1 |
| mdprc 108 12 14 000 | Alere | Captia Malaria EIA | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01315-1 |
| mdprc 107 12 14 000 | Alere LTD | Alere Actim Partus | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01323-1 |
| mdprc 101 12 14 000 | Fisher & Paykel Healthcare Limited | IW900-series Infant Warmers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01188-1 |
| mdprc 085 12 14 000 | Zimmer inc | Trilogy Bone Screws | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01271-1 |
| mdprc 084 12 14 000 | Tornier Inc | Humeral broaches Aequalis (6/6.5 diameter) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01277-1 |
| mdprc 083 12 14 000 | QIAGEN Ltd | QIAsymphony DSP Virus/Pathogen Midi Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01281-1 |
| mdprc 082 12 14 000 | DePuySynthes | Small Electric Drive | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01278-1 |
| mdprc 081 12 14 000 | Alere | Alere INRatio PT/INR Monitor System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01289-1 |
| mdprc 051 12 14 000 | Philips Healthcare | Philips HeartStart MRx Monitor/Defibrillator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01268-1 |
| mdprc 050 12 14 000 | Stryker Endoscopy | Laparoscopic Manual Instruments and Accessories | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01264-1 |
| mdprc 049 12 14 000 | IQ Medical | i-Optics’ Cassini | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01265-1 |
| mdprc 048 12 14 000 | GE Healthcare | Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01266-1 |
| mdprc 047 12 14 000 | Biomet | Biomet Orthopedics (“Biomet”) Sirius Polish Cemented Stem | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01270-1 |
| mdprc 025 12 14 001 | Philips Medizin Systeme GmbH | BrightView SPECT, BrightView X and BrightView XCT Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01224-1 |
| mdprc 026 12 14 000 | ScottCare Corp | FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01234-1 |
| mdprc 024 12 14 000 | Kimberly Clark Health Care | KimVent Microcuff Subglottic Suctioning Endotracheal Tube | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01242-1 |
| mdprc 023 12 14 000 | Carl Zeiss Meditec Inc | LumaDent Light Battery Packs | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01248-1 |
| mdprc 018 12 14 000 | Vision RT | AlignRT patient positioning | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01220-1 |
| mdprc 017 12 14 000 | Siemens Medical Solutions | syngo Imaging XS and syngo.plaza | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01235-1 |
| mdprc 016 12 14 000 | Siemens Healthcare Diagnostics Product | IMMULITE 2000 and IMMULITE 2000 Xpi | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01238-1 |
| mdprc 015 12 14 000 | Radiometer America Inc | Pico 70 Arterial Blood sampler | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01236-1 |
| mdprc 014 12 14 000 | Philips Healthcare Gamma Cameras | BrightView XCT SPECT/CT systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01226-1 |
| mdprc 013 12 14 000 | Medtronic Inc | CareLink Clinical Therapy Management Software | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01215-1 |
| mdprc 012 12 14 000 | Kerr (USA) Div Sybron Dental Specialties Inc | Silane | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01241-1 |
| mdprc 011 12 14 000 | DiaSorin Inc | LIAISON Borrelia IgG | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01240-1 |
| mdprc 010 12 14 000 | Covidien LLC | McGRATH MAC Video Laryngoscope Blade Size #2 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01239-1 |
| mdprc 009 12 14 000 | Boston Scientific | Boston Scientific AUTOGEN DR Implantable Cardioveter-Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01223-1 |
| mdprc 084 11 14 002 | HemoCue A B | HemoCue Glucose 201 Microcuvettes single packed | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01197-1 |
| mdprc 087 11 14 000 | Bausch & Lomb Inc. | Stellaris PC with Laser System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01205-1 |
| mdprc 086 11 14 000 | Covidien | Gelflex Sterile Eye Wash Normal Saline 10mL Ampoule | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01130-1 |
| mdprc 085 11 14 000 | Gambro | Revaclear and Revaclear Max Dialyzers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01214-1 |
| mdprc 083 11 14 000 | Radiometer Medical | cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01201-1 |
| mdprc 082 11 14 000 | Siemens Healthcare Diagnostics GmbH | Dimension Vista 500 Intelligent Lab System & Dimension Vista 1500 Intelligent Lab System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01192-1 |
| mdprc 081 11 14 000 | Smith & Nephew Orthopaedic | ArthroCare Corporation HipVac 50 Coblation Wand | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01203-1 |
| mdprc 192 08 13 001 | Biomet 3i Inc | Navigator Surgical Kit/Tray, Tapered Navigator Surgical Kit/Tray, Contra-Angle Torque Driver Kit, Prosthetic Instrumentation Kit, Prosthetic System Driver Tray | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00895-1 |
| mdprc 046 10 13 001 | Stryker | ADM/MDM Ball Impactor Tips and ADM Rim Impactor Tips | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01033-1 |
| mdprc 073 07 13 001 | GE Healthcare | nuclear medicine systems, Infinia nuclear medicine systems, VG and VG Hawkeye nuclear medicine systems and Helix nuclear medicine systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00695-1 |
| mdprc 048 11 14 000 | Mindray DS USA, Inc., dba Datascope Patient Monitoring | Mindray's V-Series Patient Monitors | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01173-1 |
| mdprc 047 11 14 000 | Philips Healthcare | MammoDiagnost DR | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01180-1 |
| mdprc 046 11 14 000 | Oxoid Div ThermoFisher Scientific Microbiology | Anaerobic Agar Plate | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01164-1 |
| mdprc 045 11 14 000 | Mindray DS USA, Inc., dba Datascope Patient Monitoring | Mindray V-Series Patient Monitors with 12-lead ECG interpretation capabilities | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01172-1 |
| mdprc 044 11 14 000 | Intuitive Surgical Inc | Endo Wrist One Vessel Sealer (INS-410322) for the da Vinci Si (IS3000) Surgical System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01174-1 |
| mdprc 023 11 14 000 | Oxoid Div ThermoFisher Scientific Microbiology Perth | Thioglycollate Broth 5mL. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01152-1 |
| mdprc 017 11 14 000 | Zimmer inc | NexGen Trabecular Metal Tibial Replacement Impactor Pads Contained in Trays | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01170-1 |
| mdprc 016 11 14 000 | Roche Diagnostics GmbH | AFB III Staining Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01161-1 |
| mdprc 015 11 14 000 | Biosense Webster Inc. | ThermoCool SmartTouch Catheter Family | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01156-1 |
| mdprc 114 10 14 000 | Edwards Lifesciences | Edwards Lifesciences Vent Catheter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01106-1 |
| mdprc 113 10 14 000 | Siemens Healthcare Diagnostics Product | IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi - Calcitonin Control Module | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01133-1 |
| mdprc 112 10 14 000 | 3M UNITEK Corporation | APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01135-1 |
| mdprc 103 09 14 001 | Siemens Healthcare Diagnostics | ADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) Assay | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130181 |
| mdprc 096 10 14 000 | Hospira Inc | Sapphire Administration IV Set AP424 (PCA Set) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01126-1 |
| mdprc 095 10 14 000 | Biomet Microfixation | 50mm Left Standard Ti Mandible | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01132-1 |
| mdprc 089 10 14 000 | Siemens Healthcare Diagnostics | ADVIA Centaur and ADVIA Centaur XP | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01116-1 |
| mdprc 088 10 14 000 | Pfizer Limited | Dimetapp Saline Nasal Drops for Infants | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01036-1 |
| mdprc 116 09 14 002 | Covidien | CovidienMedi-Trace Cadence Defibrillation Electrodes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130112 |
| mdprc 068 10 14 000 | Teleflex Medical | Hudson Nebuliser Adaptor - AQUAPAK | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01103-1 |
| mdprc 067 10 14 000 | Beckman Coulter | Small Form Factor Console PC | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01087-1 |
| mdprc 066 10 14 000 | Integra LifeSciences | Selector Tubing Kits Used with CUSA Ultrasonic Aspirators | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01079-1 |
| mdprc 044 10 14 000 | GE Healthcare | OEC 9800, OEC UroView 2800, OEC MiniView 6800, OEC FlexiView 8800 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01072-1 |
| mdprc 043 10 14 000 | Siemens Healthcare Diagnostics | ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01080-1 |
| mdprc 042 10 14 000 | Siemens Healthcare Diagnostics | CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01062-1 |
| mdprc 041 10 14 000 | Molnlycke Health Care AB | Microtek Basin Liners Contained in Molynlycke ProcedurePaks | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01082-1 |
| mdprc 040 10 14 000 | IMRIS | IMRIS Operating Room table (ORT300) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01078-1 |
| mdprc 039 10 14 000 | GE Healthcare | Discovery MR750 and Discovery MR750w | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01067-1 |
| mdprc 037 10 14 000 | Covidien LLC | Puritan Bennett 980 Series Ventilator System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01088-1 |
| mdprc 036 10 14 000 | Bard Access Systems | Lifemed Urinary Drainage Bag with Pump | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01058-1 |
| mdprc 035 10 14 000 | Amplitude GmbH | AMPLITUDE Orthopaedic Surgical Instruments | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01059-1 |
| mdprc 034 10 14 000 | Abbott Laboratories Inc | Abbott RealTime Assay Application CD-ROM | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01076-1 |
| mdprc 030 09 14 002 | ZOLL Medical Corp | ZOLL ProPadz Sterile Multi-Function Electrodes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130465 |
| mdprc 026 10 14 000 | Roche Diagnostics GmbH | Accu-Chek Spirit Combo Insulin Pumps | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01063-1 |
| mdprc 025 10 14 000 | CooperVision Inc. | Proclear Toric Soft Hydrophilic Contact Lenses | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01039-1 |
| mdprc 005 10 14 000 | Zimmer inc | Persona Distal Valgus Alignment Guides (supplied as part of the reusable surgical kit) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01028-1 |
| mdprc 120 09 14 000 | SIEMENS | Artis zee and Artiszeego systems used in conjunction with the A100 generator and specific lots of X-ray tube | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01035-1 |
| mdprc 119 09 14 000 | Siemens Healthcare Diagnostics Product | IMMULITE/IMMULITE 1000 - Cortisol Assay | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01023-1 |
| mdprc 118 09 14 000 | Siemens Healthcare Diagnostics GmbH | Dimension Vista Hemoglobin A1c Flex Reagent Cartridge | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01030-1 |
| mdprc 117 09 14 000 | MedionGrifols Diagnostics AG | Grifols Australia Perfect Panel cells | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01020-1 |
| mdprc 115 09 14 000 | Covidien LLC | Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01038-1 |
| mdprc 102 09 14 000 | Codman & Shurtleff Inc | Codman Neuro EDS 3 CSF External Drainage Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01009-1 |
| mdprc 028 09 13 001 | Boston Scientific Ltd | COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00906-1 |
| mdprc 101 09 14 000 | Alcon Laboratories Inc | AcrySof CACHET PHAKIC Lens | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01013-1 |
| mdprc 100 09 14 000 | Abbott Diagnostic International Ltd | m24sp Instrument System. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01010-1 |
| mdprc 082 09 14 000 | Bio-Rad Laboratories Inc | NaCl, Enzyme Test and Cold Agglutinins | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01000-1 |
| mdprc 081 09 14 000 | Ortho-Clinical Diagnostics | VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems Using Software Version 3.0 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01001-1 |
| mdprc 030 08 14 001 | GE Healthcare | Discovery XR656 Wall Stand System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00834-1 |
| mdprc 071 09 14 000 | Siemens Healthcare Diagnostics Product | Dade Innovin (Prothrombin time assay) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00873-1 |
| mdprc 070 09 14 000 | bioCSL Pty Ltd | Phenocell A 3% | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00986-1 |
| mdprc 068 09 14 000 | Device Technologies Australia Pty Ltd | Defibrillator/pacer SLIM corpuls3 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00979-1 |
| mdprc 047 06 14 001 | Covidien LLC | Puritan Bennett 840 Ventilator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00974-1 |
| mdprc 137 07 14 001 | Stryker Endoscopy | AVS ARIA Implant Inserter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129150 |
| mdprc 051 09 14 000 | Mckesson Information Solutions LLC | Horizon Cardiology Hemo | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00962-1 |
| mdprc 020 09 14 001 | Synthes Inc | Cortex Screw Ø 3.5 mm, self-tapping, length 28 mm, Stainless Steel | Swissmedic |
| mdprc 043 09 14 000 | Terumo BCT Inc | Spectra Optia Apheresis System with Software Version 11 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00963-1 |
| mdprc 042 09 14 000 | bioCSL Pty Ltd | Phenocell A 3% | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00951-1 |
| mdprc 032 09 14 000 | Vision-Sciences, Inc. | Vision Sciences Battery Charger (VANSON V-95) and rechargeable Lithium-Ion Batteries supplied with BLS-1000 portable LED light source kits or as standalone items. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00930-1 |
| mdprc 029 09 14 000 | Johnson & Johnson Medical GmbH | Omrix Pressure Regulator. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00937-1 |
| mdprc 117 08 14 001 | St. Jude Medical Inc | St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129605 |
| mdprc 086 07 14 001 | ArjoHuntleigh | Minstrel Patient Transfer Lift with Scale | BfArM |
| mdprc 019 09 14 000 | SIEMENS | V5Ms transesophageal transducer | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00943-1 |
| mdprc 018 09 14 000 | Bard Pcripheral Vascular (BPV) | Bard DuaLok Breast Lesion Localization Wire | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00946-1 |
| mdprc 005 09 14 000 | Wright Medical Technology, Inc. | CLAW and CLAW II Fixation Plates. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00914-1 |
| mdprc 004 09 14 000 | Vapotherm Inc | Vapotherm Disposable Patient Circuit System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00916-1 |
| mdprc 003 09 14 000 | Terumo BCT Inc | Spectra Optia Apheresis System, Return Line Air Detector (RLAD) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00886-1 |
| mdprc 002 09 14 000 | Siemens Healthcare Diagnostics | ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00925-1 |
| mdprc 129 10 13 001 | Zimmer inc | Trinica Ratchet Handles, Non-active implantable devices | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01092-1 |
| mdprc 116 08 14 000 | Getinge Disinfection AB | HS66 Turbo LTSF Steriliser | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00908-1 |
| mdprc 034 08 14 001 | Siemens Healthcare Diagnostics Product | Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers | BfArM |
| mdprc 049 05 14 002 | HeartWare Inc | HeartWare Ventricular Assist System batteries | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00902-1 |
| mdprc 024 12 13 002 | Beckman Coulter | UniCel DxH 600 and DxH 800 Cellular Analysis Systems. | BfArM |
| mdprc 073 08 14 000 | Steris Corp | STERIS 4085, 4085 SS and 4085 Feather Weight Leg Section (FLWS) Surgical tables | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00884-1 |
| mdprc 072 08 14 000 | SIEMENS | Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay quality control) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00874-1 |
| mdprc 071 08 14 000 | SIEMENS | Symbia T Series and Symbia Intevo Camera System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00881-1 |
| mdprc 070 08 14 000 | Olympus Winter & IBE GmbH | Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon Visera Elite, Light Source Xenon Exera III, High Flow Co2 Insufflator, Scopeguide Unit & Video System Center | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00859-1 |
| mdprc 136 03 14 001 | MAQUET Cardiovascular LLC | Intra-Aortic Balloon Pumps (IABP) | BfArM |
| mdprc 052 08 14 000 | Oxoid Ltd | Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00868-1 |
| mdprc 041 08 14 000 | St. Jude Medical Inc.. | AGA Medical Amplatzer Septal Occluder | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00609-1 |
| mdprc 033 08 14 000 | Philips Healthcare | Philips Ultrasound QLAB | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00837-1 |
| mdprc 032 08 14 000 | Bio Rad. | Amoxicillin + clavulanic acid disks | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00856-1 |
| mdprc 031 08 14 000 | Standard Dignostics | Panbio Q Fever IgM ELISA | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00792-1 |
| mdprc 138 07 14 000 | William Cook Europe ApS | TXR-ME (Tri-Ex Extraction Balloon with Multiple Sizing) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00795-1 |
| mdprc 136 07 14 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Pack | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00820-1 |
| mdprc 135 07 14 000 | In Vitro Technologies | Cooper Surgical TransWarmer Infant Transport Mattress | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00801-1 |
| mdprc 125 06 14 001 | Williams Medical Supplies Ltd | Skin Graft Knife Blades for use with Thackray Watson Cobbett and Braithwaite Skin Graft Knife | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00654-1 |
| mdprc 065 07 14 001 | Molnlycke Health Care AB | ProcedurePak | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00768-1 |
| mdprc 048 07 14 001 | Becton Dickinson & Co. (BD) | BD Vacutainer CPT Cell Preparation Tube. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00704-1 |
| mdprc 048 09 13 001 | Synthes Inc | Application Instrument for Sternal ZipFix | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00924-1 |
| mdprc 089 07 14 000 | Stryker Instruments ( Ultrasonic Surgical Aspirator System ) | Sonopet Console | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00769-1 |
| mdprc 088 07 14 000 | SIEMENS | Artis Q and Artis Q zen systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00782-1 |
| mdprc 087 07 14 000 | BrainLAB | Brainlab Patient Data Manager | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00784-1 |
| mdprc 137 03 14 001 | Stryker Communications | Shape Arm Kit Left and Shape Arm Kit Right | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126388 |
| mdprc 067 07 14 000 | Philips Healthcare | MobileDiagnost wDR. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00762-1 |
| mdprc 066 07 14 000 | Ortho-Clinical Diagnostics | VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00765-1 |
| mdprc 064 07 14 000 | Device Technologies Australia Pty Ltd | Specular Microscope SP-1P | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00771-1 |
| mdprc 063 07 14 000 | Abbott Molecular Inc Sub Abbott Laboratories | 5mL Reaction Vessels used with the m2000sp Instrument | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00764-1 |
| mdprc 060 07 14 000 | Instrumentation Laboratory | ACL Top Family of instruments (haemostasis testing systems). | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00633-1 |
| mdprc 132 05 14 001 | Philips Healthcare | Ingenia, Intera and Achieva MR Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00577-1 |
| mdprc 055 07 14 000 | Stryker Medical | InTouch Critical Care Bed | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00727-1 |
| mdprc 054 07 14 000 | Oxoid Div ThermoFisher Scientific Microbiology Perth | Thioglycollate Medium | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00728-1 |
| mdprc 053 07 14 000 | Mckesson Information Solutions LLC | Horizon Cardiology Hemo1 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00735-1 |
| mdprc 052 07 14 000 | Hill Rom Inc | Affinity Four Birthing Bed | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00713-1 |
| mdprc 051 07 14 000 | Device Technologies Australia Pty Ltd | Slide-in Plug Adaptor for Charger | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00736-1 |
| mdprc 050 07 14 000 | Siemens Healthcare Diagnostics | RAPIDQC Complete Quality Control Material | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00702-1 |
| mdprc 047 07 14 000 | Abbott Molecular Inc Sub Abbott Laboratories | m24sp Instrument System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00708-1 |
| mdprc 119 11 13 002 | Atrium Medical Corporation | Atrium Chest drains that contain an Autotransfusion (ATS) System access line | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127513 |
| mdprc 035 07 14 000 | Linear Medical Pty Ltd | Lancet, Low Flow and Micro Flow | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00695-1 |
| mdprc 034 07 14 000 | Clifford Hallam | Crepe Bandage | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00688-1 |
| mdprc 005 07 14 000 | Mayo Healthcare Pty Ltd | Multi Lumen and Pressure Injectable Central Venous Catheters | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00613-1 |
| mdprc 004 07 14 000 | AGFA Corp. | DX-D 100 Digital Radiography X-Ray System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00674-1 |
| mdprc 043 04 14 001 | GE Healthcare | OEC 9900 Workstation Monitor Spring Arm Screws | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00389-1 |
| mdprc 123 06 14 000 | Intelerad Medical Systems Inc. | INTELEPACS | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00662-1 |
| mdprc 122 06 14 000 | Better Living care | 500 Series Vertical Rails | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00602-1 |
| mdprc 029 09 13 001 | Nipro Corp | PSV Sets (Scalp Vein), Hard, 27Gx 3/4" ISO CE | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00302-1 |
| mdprc 098 06 14 000 | Siemens Medical Solutions | Axiom Artis and Artis Zee Systems with hand switch | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00648-1 |
| mdprc 097 06 14 000 | DePuySynthes | Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00646-1 |
| mdprc 096 06 14 000 | Covidien LLC | Puritan Bennett 840 Ventilator. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00653-1 |
| mdprc 095 06 14 000 | Medtronic Neuromodulation | Medtronic Duet External Drainage and Monitoring System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00631-1 |
| mdprc 093 06 14 000 | Bio-Rad Laboratories Inc | D-10 Haemoglobin Testing System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00280-1 |
| mdprc 065 06 14 000 | Siemens Healthcare Diagnostics Product | RIA Coat A Count Androstenedione | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00624-1 |
| mdprc 064 06 14 000 | Philips Healthcare | Ingenia MR FlexTrak Trolley | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00623-1 |
| mdprc 050 06 14 000 | Mentor Medical Systems | MENTOR Gel Sizers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00600-1 |
| mdprc 048 06 14 000 | Siemens Healthcare Diagnostics | ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00608-1 |
| mdprc 046 06 14 000 | Alere San Diego | Alere Triage BNP Calibrator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00619-1 |
| mdprc 025 05 14 001 | Arrow International Inc | Percutaneous Sheath Introducer Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126904 |
| mdprc 035 06 14 000 | Stryker Communications | Multiple Burs and Drills | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00593-1 |
| mdprc 033 06 14 000 | Mckesson Medical Imaging Group | Horizon Medical Imaging products | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00610-1 |
| mdprc 032 06 14 000 | Life Healthcare | VTI Bayonet 20 MHz Doppler Probe | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00607-1 |
| mdprc 031 06 14 000 | Kerr Corp | Tytin Regular Set (Dental Amalgam) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00606-1 |
| mdprc 030 06 14 000 | Becton Dickinson & Co. (BD) | BBL Crystal Enteric/Nonfermenter ID Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00599-1 |
| mdprc 016 04 14 002 | Alere San Diego | Alere Triage BNP Test for Beckman Coulter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00374-1 |
| mdprc 076 01 14 002 | Leica Biosystems Newcastle Ltd | Novocastra Liquid Mouse Monoclonal Antibody | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126925 |
| mdprc 110 12 13 001 | Hospira Inc | INFUSION PUMP, PLUM LifeCare 5000 Series and PLUM XL Families of Infusers Broken Door Roller Assembly | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125503 |
| mdprc 052 05 14 001 | Siemens Healthcare Diagnostics GmbH | ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126652 |
| mdprc 008 06 14 000 | Roche Diagnostics GmbH | Accu-Chek Mobile Blood Glucose Meter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00592-1 |
| mdprc 006 06 14 000 | SIEMENS | ACUSON S2000 and ACUSON S3000 Ultrasound Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00563-1 |
| mdprc 004 06 14 000 | Draeger Medical Systems Inc | Disposable Ventstar 180cm Circuit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00567-1 |
| mdprc 141 05 14 000 | Biosense Webster Inc | ThermoCool SF NAV Catheter Family | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00588-1 |
| mdprc 136 05 14 000 | Invacare Corporation | Mobile Shower and Toilet Commode Aquatec Ocean VIP | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00518-1 |
| mdprc 135 05 14 000 | St. Jude Medical Inc | Axium Neurostimulator Leads | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00531-1 |
| mdprc 134 05 14 000 | REM Systems | Polyurethane Nasogastric Feeding Tube | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00561-1 |
| mdprc 133 05 14 000 | Philips Healthcare | Battery Packs used with SmartMonitor 2 Professional Series Monitors | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00585-1 |
| mdprc 131 05 14 000 | Beckman Coulter | Ultrasonic Transducer Kits used with the Access Family of Immunoassay Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00562-1 |
| mdprc 130 05 14 000 | Baxter Healthcare | Baxter Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshell | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00568-1 |
| mdprc 085 02 14 001 | SIEMENS | AXIOM Artis Systems. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00136-1 |
| mdprc 047 05 14 001 | Alere | Alere INRatio2 PT/INR Heparin Insensitive Test Strips | BfArM |
| mdprc 097 05 14 000 | GE Healthcare | Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00543-1 |
| mdprc 107 04 14 001 | Medtronic Inc | Occluded Extension Tubing in Refill Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126819 |
| mdprc 070 05 14 000 | SIEMENS | MAGNETOM Aera | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00515-1 |
| mdprc 069 05 14 000 | Hill Rom Inc | Hill-Rom MC700 General Ward Bed | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00537-1 |
| mdprc 068 05 14 000 | Biomet Inc | G7 Positioning Guide Rod & G7 Positioning Guide Post | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00529-1 |
| mdprc 067 05 14 000 | Baxter Healthcare | MiniCap Extended Life PD Transfer Set with Twist Clamp | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00536-2 |
| mdprc 064 11 13 002 | Welch Allyn Protocol Inc | Welch Allyn Propaq LT and Propaq 802 with Nellcor SpO2 | NCAR |
| mdprc 055 05 14 000 | ConMed Corporation | ConMed MacroLyte Premie Dispersive Electrode | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00522-1 |
| mdprc 054 05 14 000 | Wright Medical Technology Inc | PATH Thread Cup Adaptor | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00513-1 |
| mdprc 053 05 14 000 | Thermo Fisher Scientific Microbiology Perth inc | Mueller Hinton-HTM (culture media) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00454-1 |
| mdprc 051 05 14 000 | Oxoid Div ThermoFisher Scientific Microbiology Perth | Oxoid Antimicrobial Susceptibility Testing Penicillin (P1) Discs | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00506-1 |
| mdprc 050 05 14 000 | Ortho-Clinical Diagnostics | VITROS 4600 Chemistry System, VITROS 5600 Integrated System and VITROS 5,1 FS Chemistry System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00502-1 |
| mdprc 048 05 14 000 | FUJIFILM Medical Systems | Synapse Cardiovascular (CV) Client application | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00482-1 |
| mdprc 087 02 14 002 | Siemens Healthcare Diagnostics Product | VersaCell connected to IMMULITE 2000/IMMULITE 2000 XPi analysers | TGA, Swissmedic, BfArM |
| mdprc 031 05 14 000 | Stryker Endoscopy | 12-Instrument Sterilization Tray | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00480-1 |
| mdprc 030 05 14 000 | Medtronic Navigation Inc | Medtronic Navigation Sterile Devices | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00500-1 |
| mdprc 026 05 14 000 | GE Healthcare | Centricity PACS RA1000 Workstations. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00442-1 |
| mdprc 004 05 14 002 | Leica Biosystems | Bond Ready-To-Use Primary Antibody Thyroglobulin (1D4) | RC-2014-RN-00476-1 & MHRA (2014/004/017/601/009) |
| mdprc 005 05 14 000 | GE Healthcare | Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w, Discovery MR750w and Discovery MR750w | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00464-2 |
| mdprc 003 05 14 000 | Synthes | Craniomaxillofacial (CMF) Distraction System, BC Distractor Body, end activated, with Universal Joint for CMF Distractor | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00478-1 |
| mdprc 002 05 14 000 | FUJIFILM Medical Systems | FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1 with Biopsy unit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00479-1 |
| mdprc 014 01 14 001 | Siemens Healthcare Diagnostics Product | Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00002-1 |
| mdprc 057 04 14 001 | Covidien LLC | Pipeline Embolization Device and Alligator Retrieval Device | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00415-1 |
| mdprc 108 04 14 000 | Ortho-Clinical Diagnostics | enGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) v8.06 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00414-1 |
| mdprc 106 04 14 000 | Life Technologies Corporation | IVD,Dynabeads HLA (Human Leucocyte Antigen) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00416-1 |
| mdprc 105 04 14 000 | Edwards Lifesciences | Fem-Flex II Arterial Cannulae | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00422-1 |
| mdprc 104 04 14 000 | Covidien Ltd | EverCross .035" OTW PTA Catheter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00431-1 |
| mdprc 103 04 14 000 | Bayer Healthcare LLC | MEDRAD Continuum Infusion Pump | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00426-1 |
| mdprc 102 04 14 000 | Baxter Healthcare | Potassium 10mmol in 0.225% Sodium Chloride and 10% Glucose (500ml) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00421-1 |
| mdprc 101 04 14 000 | Alcon LenSx, Inc | LenSx Laser System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00424-1 |
| mdprc 169 02 14 001 | Johnson & Johnson Medical GmbH | Proceed Surgical Mesh. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00189-1 |
| mdprc 058 04 14 000 | GE Healthcare | Vivid E9 Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00411-1 |
| mdprc 093 03 14 001 | Baxter Healthcare | HomeChoice PRO Automated Peritoneal Dialysis (PD) System | TGA, MHRA |
| mdprc 049 04 14 000 | SIEMENS | ARTIS Zeego | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00383-1 |
| mdprc 048 04 14 000 | Philips Healthcare Gamma Cameras | ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00405-1 |
| mdprc 044 04 14 000 | GE Healthcare | Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00385-1 |
| mdprc 042 04 14 000 | Solta Medical, Inc. | Fraxel Dual 1550/1927 Laser Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00402-1 |
| mdprc 094 03 14 001 | Philips Healthcare | Philips HeartStart Home and OnSite (HS1) Automated External Defibrillators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125837 |
| mdprc 017 04 14 000 | Baxter Healthcare | Colleague Volumetric Infusion Pumps | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00384-1 |
| mdprc 048 12 13 001 | Beckman Coulter | IVDs, LH 750 and LH 780 Hematology Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01284-1 |
| mdprc 134 03 14 000 | Synthes Inc | Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00354-1 |
| mdprc 133 03 14 000 | Device Technologies Australia Pty Ltd | Cup Removal Instruments | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00154-1 |
| mdprc 028 03 14 001 | Philips Healthcare | Philips HeartStart FR3 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125857 |
| mdprc 115 03 14 000 | ZOLL Medical Corp | Zoll X Series Defibrillators with system | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00348-1 |
| mdprc 168 02 14 001 | Integra LifeSciences ORTHOPAEDIC | HINTEGRA Standard and Revision tibial and talar components | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00200-1 |
| mdprc 101 03 14 001 | Draeger Medical Systems Inc | Latex Test Lungs and Latex Rebreathing Bags | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00332-1 |
| mdprc 100 03 14 000 | Smiths Medical | HOTLINE Fluid Warming Sets | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00344-1 |
| mdprc 099 03 14 000 | Siemens Healthcare Diagnostics GmbH | Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE) Flex Reagent Cartridge | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00334-1 |
| mdprc 098 03 14 000 | Unomedical Inc | Unomedical Feeding Tubes | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00278-1 |
| mdprc 097 03 14 000 | Boston Scientific | CAPIO Sutures | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00335-1 |
| mdprc 096 03 14 000 | Integra LifeSciences Ltd | CUSA Excel+ Sterile Torque Disposable Wrench (23kHz) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00306-1 |
| mdprc 095 03 14 000 | Zimmer inc | Metal-Backed Patella from Natural-Knee II System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00336-1 |
| mdprc 092 03 14 000 | SIEMENS | Symbia T and Symbia T2 Camera System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00340-1 |
| mdprc 073 03 14 000 | Intelerad Medical Systems Inc. | INTELEVIEWER, Versions 3.8.1 P355 and up | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00292-1 |
| mdprc 071 03 14 000 | Medtronic Neuromodulation | Brain and Spinal Cord Stimulators | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00289-1 |
| mdprc 070 03 14 000 | Medtronic Neuromodulation | Spinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient Programmers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00288-1 |
| mdprc 069 03 14 000 | bioMerieux Inc | FB Reagent, ZYM B Reagent, API Listeria and API NH | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00293-1 |
| mdprc 032 03 14 001 | Thermo Fisher Scientific Oy | Indiko and Indiko Plus Chemistry Analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00212-1 |
| mdprc 016 03 14 001 | Accumetrics Inc | VerifyNow Iib/IIIa 25 Test and VerifyNow Iib/IIIa 10 Test | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00273-1 , http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125633 |
| mdprc 091 01 14 001 | Roche Diagnostics Ltd | Elecsys HIV combi PT assay | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00030-1 |
| mdprc 027 03 14 000 | Covidien | Head Positioning Devices | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00215-1 |
| mdprc 026 03 14 000 | BrainLAB | ExacTrac 6.0.3 Patient Positioning System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00269-1 |
| mdprc 017 03 14 000 | Heartsine Technologies | Samaritan PAD 500P | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00243-1 |
| mdprc 092 01 14 001 | Siemens Healthcare Diagnostics Product | Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00036-1 |
| mdprc 105 02 14 001 | ThermoFisher Scientific Microbiology Perth | Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00155-1 |
| mdprc 170 02 14 000 | The Binding Site | SPAPLuS Analysers. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00098-1 |
| mdprc 164 02 14 000 | Philips Healthcare | Philips HeartStart MRx Monitor/Defibrillator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00188-1 |
| mdprc 163 02 14 000 | Baxter Healthcare | Aquarius Regional Citrate Anticoagulation (RCA) Haemofiltration Device | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00095-1 |
| mdprc 143 02 14 000 | GE Healthcare | Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00179-1 |
| mdprc 141 02 14 000 | Siemens Healthcare Diagnostics | ADVIA Centaur XP Immunoassay System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00181-1 |
| mdprc 140 02 14 000 | Carl Zeiss Meditec Inc | OPMI Pentero surgical microscope system (PC 2.1) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00174-1 |
| mdprc 139 02 14 000 | Acumed LLC | Volar Distal Radius (VDR) Proximal Targeting Guide | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00162-1 |
| mdprc 107 02 14 000 | The Binding Site | The Binding Site SPAPLuS analyser | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00150-1 |
| mdprc 106 02 14 000 | LUTONIX | LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation Catheter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00153-1 |
| mdprc 104 02 14 000 | bioMerieux Inc | Etest Ertapenem Foam and Single Blister Packs (antibiotic susceptibility test). | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00159-1 |
| mdprc 020 12 13 001 | BrainLAB | Instrument Star Unit ML (Calibration with ICM4) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124519 |
| mdprc 084 02 14 000 | GE Healthcare | Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00143-1 |
| mdprc 050 02 14 000 | Siemens Medical Solutions | MRI-Stretcher non-magnetic | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00125-1 |
| mdprc 049 02 14 000 | GE Healthcare | Precision 500D and Proteus XR/a with Wireless Digital Radiography Option | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00121-1 |
| mdprc 048 02 14 000 | GE Healthcare | Solar 8000M and Solar 8000i Patient Monitor software | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00114-1 |
| mdprc 012 02 14 001 | Covidien LLC | Puritan Bennett 840 Ventilator and 700 Series (740 and 760) Ventilators | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00093-1 |
| mdprc 136 12 13 001 | Becton Dickinson & Co. (BD) | BD BACTED FX - Top Unit and Bottom Unit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125075 |
| mdprc 027 02 14 000 | SIEMENS | ACUSON SC2000 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00076-1 |
| mdprc 024 02 14 000 | Mckesson Medical Imaging Group | Horizon Medical Imaging (HMI) products software | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00101-1 |
| mdprc 004 02 14 001 | SynthesInc | Holding Forceps for SynReam Reaming Rod 2.5 mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00097-1 |
| mdprc 103 01 14 001 | Baxter Healthcare | Vented Spike with Clearlink | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00033-1 |
| mdprc 104 01 14 000 | Schell Medical | Manual Pulmonary Resuscitator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00025-1 |
| mdprc 102 01 14 000 | St. Jude Medical Inc | ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev.0 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00034-1 |
| mdprc 094 01 14 000 | Carestream Health Inc Div Onex Corp | Kodak DirectView DR 7500 Systems. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00031-1 |
| mdprc 093 01 14 000 | Philips Healthcare Gamma Cameras | BrightView SPECT, BrightView X and BrightView XCT . | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00035-1 |
| mdprc 083 01 14 001 | International Technidyne Corporation | Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01364-1 |
| mdprc 075 01 14 000 | Siemens Medical Solutions | Magnetom Spectra Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00023-1 |
| mdprc 067 01 14 000 | Matrix Surgical Pty Ltd | Matrix Surgical Laparoscopic Spatula with cable | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00020-1 |
| mdprc 046 01 14 000 | GE Healthcare | Various Innova Cardiovascular X-Ray Systems. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00018-1 |
| mdprc 045 01 14 000 | GE Healthcare | Precision 500D / Precision MPI / Precision RXI X-ray imaging systems equipped with LCD Video Monitor | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00016-1 |
| mdprc 088 11 13 001 | Ansell Healthcare Products LLC | Ansell Sandel Weighted Safety Scalpel | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124491 |
| mdprc 146 10 13 001 | Medtronic Inc | HYBRID Guide Wires, ATTAIN | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01086-1 |
| mdprc 027 01 14 000 | SIEMENS | Ultrasound imaging system, ACUSON SC2000 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00005-1 |
| mdprc 026 01 14 000 | Smith & Nephew Orthopaedic | Joint prosthesis, Knee, Femoral Implant, Journey BCS Knee Replacement System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00004-1 |
| mdprc 025 01 14 000 | Siemens Healthcare Diagnostics Product | Immunoassay analyser, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00003-1 |
| mdprc 174 12 13 000 | Stryker Orthopaedics | Trident Tritanium Acetabular Window Trials Case | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01356-1 |
| mdprc 173 12 13 000 | Highland Metals Inc. | SuperElastic NiTi Archwires | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01337-1 |
| mdprc 171 12 13 000 | Siemens Healthcare Diagnostics Product | RAPIDLyte Arterial Blood Sampling Line Draw Syringes | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01310-1 |
| mdprc 170 12 13 000 | Life Healthcare | Laparascopic inserts with tube, 3.00mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01307-1 |
| mdprc 169 12 13 000 | Philips Healthcare | Brilliance iCT with Software Version 4.1.0.19260 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01333-1 |
| mdprc 049 11 13 001 | Baxter Healthcare | 15L Cycler Drainage Bag | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01096-1 |
| mdprc 156 11 13 001 | Smiths Medical | Medfusion 4000 Syringe Infusion Pump. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124427 |
| mdprc 159 12 13 000 | Johnson & Johnson Medical GmbH | EVOTECH Endoscope Cleaner and Reprocessor (ECR) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01344-1 |
| mdprc 158 12 13 000 | GE Healthcare | Giraffe Stand Alone, Giraffe Warmer Integrated, Panda Warmer Integrated, Panda Freestanding Warmer Integrated Resuscitation Systems with Blenders, Resuscitation System field upgrade kits with Blender | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01334-1 |
| mdprc 172 11 13 002 | Abbott Diabetes Care Div Abbott Laboratories Inc | FreeStyle Lite Blood Glucose Test Strips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123972 |
| mdprc 141 12 13 000 | Welch Allyn Protocol Inc | Acuity Central Monitoring Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01319-1 |
| mdprc 138 12 13 000 | GE Healthcare | Mobile X-Ray Systems, Optima XR220amx Mobile X-Ray Systems. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01321-1 |
| mdprc 137 12 13 000 | Ellex Medical Pty Ltd | KARMA Corneal Inlay | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01254-1 |
| mdprc 129 12 13 000 | Medrad Inc | Medrad Veris MR Vital Signs Monitors | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01312-1 |
| mdprc 128 12 13 000 | Siemens Medical Solutions | Scanning Systems, SOMATOM CT System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01317-1 |
| mdprc 111 12 13 000 | Integra NeuroSciences | CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01300-1 |
| mdprc 103 12 13 000 | GE Healthcare | X-Ray Imaging Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01299-1 |
| mdprc 102 12 13 000 | Carestream Health Inc Div Onex Corp | DRX Revolution Mobile X-Ray System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01269-1 |
| mdprc 096 12 13 000 | Boucher & Muir | Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mL | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01262-1 |
| mdprc 095 12 13 000 | Bio-Rad Laboratories Inc | Haemoglobin Testing System, D-10 Dual Program Reorder Pack | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01258-1 |
| mdprc 077 12 13 000 | GE Healthcare | Resuscitation Systems , Giraffe and Panda Resuscitation Systems with Blenders | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01295-1 |
| mdprc 076 12 13 000 | B Braun Medical Inc | SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01289-1 |
| mdprc 075 12 13 000 | Elekta Limited | Volume Imaging System (XVI) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01291-1 |
| mdprc 074 12 13 000 | Elekta Limited | Integrity Digital Linear Accelerator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01290-1 |
| mdprc 073 12 13 000 | Carestream Health Inc Div Onex Corp | Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream Premium Wall Stand and Kodak DirectView DR 7500 System with Full FeaturedWall Stand | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01285-1 |
| mdprc 072 12 13 001 | Sorin Group | Sorin Perfusion System - S5/C5 Heart Lung Machine | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01283-1 |
| mdprc 071 12 13 000 | Siemens Healthcare Diagnostics GmbH | (IVD), Dimension Vista Systems, Cyclosporine (CSA) Flex reagent cartridge | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01297-1 |
| mdprc 056 12 13 000 | Ultimate Medical Ltd | Tracheal tube | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00041-1 |
| mdprc 052 12 13 000 | Smiths Medical | Epidural Minipack Systems, Anaesthesia Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01154-1 |
| mdprc 049 12 13 000 | Hospira Inc | Infusion Pumps, GemStar Phase 3 or Phase 4 Infusion Pumps. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01251-1 |
| mdprc 047 12 13 000 | Ortho-Clinical Diagnostics | VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01270-1 |
| mdprc 046 12 13 000 | Elekta Limited | X-ray Volume Imaging System (XVI), | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01287-1 |
| mdprc 171 11 13 001 | Sorin Group | REPLY and ESPRIT Pacemakers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01229-1 |
| mdprc 118 11 13 001 | Boston Scientific | Vessix Generator System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01213-1 |
| mdprc 023 12 13 000 | GE Healthcare | PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01265-1 |
| mdprc 022 12 13 000 | GE Healthcare | Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i, MacLab / ComboLab | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01255-1 |
| mdprc 021 12 13 000 | Leica Microsystems Inc. | Leica M525 F50 Surgical Microscope with XY-Unit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01256-1 |
| mdprc 019 12 13 000 | Elekta Limited | XiO versions 4.50 and higher | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01278-1 |
| mdprc 018 12 13 000 | Ortho-Clinical Diagnostics | Calibration Diskette and Assay Data Disks used with VITROS chemistry instruments | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01257- |
| mdprc 005 12 13 000 | Zimmer inc | Prostheses, Joint, Knee , Prostheses, Joint, Hip , Nails, Bone , Pins, Bone , Plates, Bone , Orthopedic Internal Fixation Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01250-1 |
| mdprc 004 12 13 000 | Zimmer inc | Trabecular Metal Reverse Shoulder Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01243-1 |
| mdprc 002 12 13 000 | Ortho-Clinical Diagnostics | Micro Well Shuttle Weight used in VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01249-1 |
| mdprc 001 12 13 000 | GE Healthcare | Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01234-1 |
| mdprc 159 11 13 000 | Ortho-Clinical Diagnostics | IVD, VITROS Chemistry Products K+ Reagent Slides. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01238-1 |
| mdprc 158 11 13 000 | Boston Scientific Ltd | TWISTER PLUS Rotatable Retrieval Device 22mm and 26mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01241-1 |
| mdprc 157 11 13 000 | Stryker Instruments | Modular Finishing Instrument Tray Assembly | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01246-1 |
| mdprc 115 11 13 001 | Medtronic Endovascular Therapies | IN.PACT Amphirion Drug-Eluting Balloon (DEB) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01153-1 |
| mdprc 129 11 13 000 | FHC Inc | Star Drive Frame Adapters and Positioners | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01134-1 |
| mdprc 063 11 13 001 | Boston Scientific Ltd | Ureteral Access Sheath Set used with Boston Scientific 13F/15F Navigator HD | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01141-1 |
| mdprc 029 10 13 001 | Beckman Coulter Inc | IVD : ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry Analysers (chemical chemistry analysers) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01012-1 |
| mdprc 037 08 13 001 | Ortho-Clinical Diagnostics | VITROS Chemistry Products MicroSlides | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00773-1 |
| mdprc 117 11 13 000 | Siemens Healthcare Diagnostics GmbH | BFT II Analyser, An in vitro diagnostic medical device (IVD). | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01174-1 |
| mdprc 116 11 13 000 | Baxter Healthcare | Vented Spike Adapters | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00948-1 |
| mdprc 051 10 13 001 | Carestream Health | Carestream PACS Client Workstation | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01022-1 |
| mdprc 111 11 13 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Chemistry Systems ( ADVIA 1650, ADVIA 1800, ADVIA 2400 ) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01158-1 |
| mdprc 110 11 13 000 | Stryker | Stryker NV Excelsior, NV Neuroform 3EZ-3.0x15mm and 3EZ-3.5x15mm Microcatheters | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01156-1 |
| mdprc 062 11 13 002 | Stryker | Teflon Tube T2 Humerus, Sterile | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01151-1 |
| mdprc 089 11 13 000 | Life Technologies Corporation | IVD : AcroMetrix PeliSpy Sero Control Type 36 and Type 38 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00083-2 |
| mdprc 066 11 13 000 | GE Healthcare | CARESCAPE Monitor B850 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01136-1 |
| mdprc 065 11 13 000 | Varian Medical Systems | Linear accelerator system. Clinac, Trilogy, Trilogy Tx, Novalis Tx and Unique accelerators, software versions 7.x, 8.x and 9.0 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01133-1 |
| mdprc 061 11 13 000 | Philips Healthcare Gamma Cameras | ADAC ARGUS Gamma Camera Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01149-1 |
| mdprc 051 11 13 000 | Hill Rom | ClinActiv and ClinActiv Plus Therapy Surface | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01108-1 |
| mdprc 050 11 13 000 | FUJIFILM Medical Systems | X-Ray System , FCR Go 2 (FCR-MB201) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00089-2 |
| mdprc 048 11 13 000 | Fenwal | Fenwal Transfer Pack 150ml with spike coupler | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2012-RN-01290-1 |
| mdprc 157 10 13 001 | Siemens Healthcare Diagnostics GmbH | X-ray, digital acquisition systems Direct digital radiography. Ysio. | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01083-1 |
| mdprc 133 10 13 001 | Alere San Diego | IVD : Panbio Barmah Forest Virus IgM ELISA | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01106-1 |
| mdprc 015 11 13 000 | Philips Healthcare | MDC PACS | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01110-1 |
| mdprc 014 11 13 000 | Siemens Medical Solutions | E.cam and Symbia E systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01118-1 |
| mdprc 013 11 13 000 | GE Healthcare | CARESCAPE Monitor B850 and CARESCAPE Monitor B650 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01109-1 |
| mdprc 010 11 13 000 | Baxter Healthcare | Homechoice Pro APD System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01117-1 |
| mdprc 008 11 13 000 | Abbott Point of Care | Coagulation assay kit, i-STAT PT/INR cartridge | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01119-1 |
| mdprc 147 10 13 001 | Philips Healthcare | Diagnostic Ultrasound System, EPIQ 7 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01085-1 |
| mdprc 067 10 13 001 | Stryker | TPS MicroDriver | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01048-1 |
| mdprc 003 11 13 000 | Synthes Inc | 8.5 mm Flexible Intramedullary Nailing System Reamer Heads | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01102-1 |
| mdprc 168 10 13 000 | Device Technologies Australia Pty Ltd | Vygon Nutrisafe Syringe Feeding Pumps | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01065-1 |
| mdprc 167 10 13 000 | Device Technologies Australia Pty Ltd | Reliance Endoscope Processing System (EPS). | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01053-1 |
| mdprc 166 10 13 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products Na+ Slides and Calibrator Kit 2 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01099-1 |
| mdprc 145 10 13 000 | Vision-Sciences, Inc. | Novacell Battery Charger supplied with the BLS-1000 Light Source set | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01091-1 |
| mdprc 134 10 13 000 | GE Healthcare | Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01089-1 |
| mdprc 132 10 13 000 | Applied Medical Resources | Inzii 12/15mm Retrieval System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01090-1 |
| mdprc 131 10 13 000 | RaySearch Laboratories AB | RayStation | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01103-1 |
| mdprc 130 10 13 000 | Thermo Fisher Scientific Inc. | CEDIA Tobramycin II Assay | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01097-1 |
| mdprc 098 10 13 000 | Philips Healthcare | Picture archiving and communication system , IntelliSpace PACS 4.4 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01072-1 |
| mdprc 097 10 13 000 | Baxter Healthcare | Xenograft,TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI GUARD | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01036-1 |
| mdprc 096 10 13 000 | Vygon UK Ltd | Vygon Purple Nutrisafe Feeding Tube 10 FR | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01043-1 |
| mdprc 095 10 13 000 | Med-Chem Surgical Pty Ltd | Electrosurgical electrode, PEB01H Diathermy Pencil | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01032-1 |
| mdprc 094 10 13 001 | GE Healthcare | Various Nuclear Medicine Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01062-1 |
| mdprc 070 10 13 000 | Philips Healthcare | Monitoring Systems, Physiologic , Expression Information Portals Used with Expression MRI Patient Monitoring Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01052-1 |
| mdprc 069 10 13 000 | bioMerieux Inc | IVD , VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses the matrix-assisted laser desorption / ionization (MALDI) mass spectrometry method) | http://www.tga.gov.au/SARA/arn-report.aspx |
| mdprc 068 10 13 000 | Hospira Inc | Sapphire Multi Therapy Pump with software Rev09Ver07 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01041-1 |
| mdprc 066 10 13 000 | GE Healthcare | Avance, Amingo, Aisys anesthesia devices (software version 8.00) and Avance CS anesthesia devices (with software version 10.00) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01039-1 |
| mdprc 032 10 13 000 | Medtel Pty Ltd | Magstim 90mm High Power Coil | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01014-1 |
| mdprc 030 10 13 000 | Synthes Inc | Plate Medial Tibia 4 Hole Standard and Small Proximal Medial Tibia 4 Hole 112 mm Titanium Sterile, TomoFix | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01018-1 |
| mdprc 028 10 13 000 | Beckman Coulter | IVD : UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01021-1 |
| mdprc 027 10 13 000 | bioMerieux Inc | IVD, TREPANOSTIKA TP Recombinant Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00174-1 |
| mdprc 097 09 13 001 | BD Biosciences | BBL MGIT Mycobacteria Growth Indicator Tube | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00975-1 |
| mdprc 018 10 13 000 | FIAB SpA | FIAB Ultrasound Transmission and IPL Transparent Gel | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00165-1 |
| mdprc 122 09 13 000 | Fluoron GmbH | Fluoron Gas Tamponades | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00266-1 |
| mdprc 121 09 13 000 | Beckman Coulter | IVD : Beckman Coulter LH 750 & 780 Hematology Analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01019-1 |
| mdprc 120 09 13 000 | Siemens Healthcare Diagnostics | Diagnostic blood gas analyser, RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01001-1 |
| mdprc 119 09 13 000 | Philips Healthcare | Ultrasound imaging, EPIQ 7 Ultrasound system | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01011-1 |
| mdprc 111 09 13 000 | Stryker Endoscopy | Vision Mounting Arms Used with Video Carts | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00976-1 |
| mdprc 110 09 13 000 | Kerr Corp | NX3 Try-In Gel Syringe Refills, Bleach | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00983-1 |
| mdprc 095 09 13 000 | BD Biosciences | IVD : BD HLA-B27 Kit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00249-1 |
| mdprc 094 09 13 000 | Siemens Healthcare Diagnostics GmbH | IVD : LOCI Cardiac Troponin I Calibrator | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00972-1 |
| mdprc 093 09 13 000 | Medtronic | Angioplasty balloon dilatation catheter , NC Sprinter RX Balloon Dilatation Catheter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00973-1 |
| mdprc 092 09 13 000 | Carestream Health | Mobile X-ray System, DRX Revolution, DRX Mobile Retrofit & DRX Transportable | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00970-1 |
| mdprc 089 07 13 002 | HemoCue A B | Glucose analyser, laboratory, HemoCue Glucose 201 Microcuvettes, single packed | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00694-1 |
| mdprc 066 09 13 001 | Maquet Cardiopulmonary AG | heart-lung bypass system, CARDIOHELP-I | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00946-1 |
| mdprc 081 09 13 000 | SIEMENS | x-ray system , Artis Systems running Artis VC1x software | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00966-1 |
| mdprc 080 09 13 000 | Grifols Australia | IVD : Grifols Australia AHG Cards | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00947-1 |
| mdprc 079 09 13 000 | GE Healthcare | Anaesthesia Machines, Engstrom Ventilator & Aespire View, Aisys and Avance | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00953-1 |
| mdprc 078 09 13 000 | Covidien Ltd | Argyle Single Lumen Polyurethane Umbilical Vessel Catheter | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00971-1 |
| mdprc 077 09 13 000 | Alere LTD | IVD : Panbio Barmah Forest Virus IgM ELISA | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00967-1 |
| mdprc 054 09 13 001 | Philips Healthcare | Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00941-1 |
| mdprc 076 09 13 000 | Roche Diagnostics Ltd | IVD, Cobas b 101 HbA1c Test | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00954-1 |
| mdprc 065 09 13 000 | Howard Wright Limited | Howard Wright Limited Hospital Beds and Stretchers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00936-1 |
| mdprc 064 09 13 000 | Biomet 3i Inc | Dental Implants , Bellatek Zirconia Abutments | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00939-1 |
| mdprc 063 09 13 000 | Biomet 3i Inc | Biomet 3i Dental Implants | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00938-1 |
| mdprc 062 09 13 000 | Leica Microsystems Inc. | Leica Ceiling Mounts | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00935-1 |
| mdprc 053 09 13 000 | Philips Healthcare | BrightView XCT | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00944-1 |
| mdprc 052 09 13 000 | BD Diagnostic Systems | BD Epilor plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00922-1 |
| mdprc 047 09 13 000 | Siemens Healthcare Diagnostics | ADVIA 1200, 1650, 1800 and 2400 Clinical Chemistry Systems | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00933-1 |
| mdprc 046 09 13 000 | Seating Dynamics Pty Ltd | Smart Drive Wheelchair Power Assist Model | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00914-1 |
| mdprc 045 09 13 000 | Roche Diagnostics Ltd | IVD : COBAS INTEGRA 800 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00926-1 |
| mdprc 031 09 13 001 | Smith & Nephew Orthopaedic | GENESIS II PS Articular Inserts | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00912-1 |
| mdprc 030 09 13 000 | Siemens Healthcare Diagnostics Product | Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analysers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00915-1 |
| mdprc 026 09 13 000 | GE Healthcare | DASH, PDM and Tram models | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00258-1 |
| mdprc 011 09 13 000 | Hoya Corporation | PENTAX Gas/Water Feeding Valve | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00909-1 |
| mdprc 002 09 13 000 | Bio Rad | Liquichek ToRCH Plus IgM Control - Positive | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00355-1 |
| mdprc 182 08 13 000 | Siemens Healthcare Diagnostics | IVD : Berichrom Heparin | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00904-1 |
| mdprc 173 08 13 000 | Smith & Nephew Orthopaedic | Internal fixation device, Sterile K-Wire and Steinmann Pin Products | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00897-1 |
| mdprc 172 08 13 000 | Baxter Healthcare | Infusion Pumps, Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00889-1 |
| mdprc 169 08 13 000 | Alpine Medical Pty Ltd | Sterile Chlorohexidine Gluconate/Alcohol Swabs | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00887-1 |
| mdprc 166 08 13 000 | Siemens Healthcare Diagnostics GmbH | Data Management System , EasyLink | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00893-1 |
| mdprc 165 08 13 000 | CoreMed Pty Ltd | Ear ventilation tubes , Fluoroplastic shepard button, 1.15mm and Fluoroplastic collar button, 1.25mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00888-1 |
| mdprc 164 08 13 000 | Philips Healthcare | imaging system TF PET/CT, Ingenuity | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00891-1 |
| mdprc 125 08 13 001 | MAQUET Inc | Operating room device management system , Secondary 19" Touchscreen - TEGRIS System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00851-1 |
| mdprc 040 08 13 001 | Smith & Nephew Orthopaedic | synovial fluid supplementation substance, Durolane 3ml | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00779-1 |
| mdprc 103 08 13 001 | Smith & Nephew inc | Bio-Absorbable Suture Anchors | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00844-1 |
| mdprc 136 08 13 000 | Ortho-Clinical Diagnostics | CK-MB Calibrators, VITROS Immunodiagnostic Products | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00367-1 |
| mdprc 135 08 13 000 | Proact Medical LTD | Adult CO2 Sampling Oxygen Mask, OxyCap | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00356-1 |
| mdprc 133 08 13 000 | Oxoid Ltd | Oxoid Antimicrobial Susceptibility Discs with Augmentin (Amoxycillin and Clavulanic acid - AMC3) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00865-1 |
| mdprc 132 08 13 000 | GE Healthcare | Anesthesia Unit Vaporizers , Tec 6 and Tec 6 Plus Vaporizers | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00845-1 |
| mdprc 066 08 13 001 | Leica Microsystems Inc. - LAB | Bond Polymer Refine Red Detection System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00824-1 |
| mdprc 107 08 13 000 | 3M Healthcare | Cast Padding, 3M Scotchcast Wet or Dry Cast Padding | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00861-1 |
| mdprc 106 08 13 000 | Megadyne Medical Products Inc | E-Z Clean, L-Wire Laparoscopic Electrode Split Stem, 45cm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00854-1 |
| mdprc 105 08 13 000 | Bio Rad | (IVD), Liquichek Sedimentation Rate Control, Level 2 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00841-1 |
| mdprc 104 08 13 000 | Philips Healthcare | CT imaging, MX 16-Slice | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00849-1 |
| mdprc 102 08 13 000 | Draeger Medical Inc | Fabius Anaesthesia Machine | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00835-1 |
| mdprc 101 08 13 000 | Smiths Medical | Portex Blue Line Disposable Inner Cannula, 7mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00828-1 |
| mdprc 100 08 13 000 | GE Healthcare | Temperature Probes , Model M1024229 9 Fr Disposable General Purpose Temperature Probes | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00807-1 |
| mdprc 093 08 13 000 | Device Technologies Australia Pty Ltd | Ultrasonic bath efficacy indicator, STF Load Check Indicators | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00416-1 |
| mdprc 092 08 13 000 | Hill Rom Inc | Beds, Electric, Hill-Rom VersaCare VC 755 Bed | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00331-1 |
| mdprc 091 08 13 000 | A-dec Inc | A-dec 311 Chair and A-dec 361 Support Centre | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00380-1 |
| mdprc 084 08 13 000 | Gerontic & General Products Pty Ltd | LifeCare P5 Premium Bed | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00448-1 |
| mdprc 083 08 13 000 | Laerdal Pty Ltd | Receptal 1000 mL liner and canister, Laerdal Suction Unit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00440-1 |
| mdprc 082 08 13 000 | Beckman Coulter | IVD, automated , Access 2 Immunoassay System with Software Version 3.4 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00469-1 |
| mdprc 192 07 13 001 | Nestle Healthcare Nutrition | Compat Nasogastric Feeding Tube | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00764-1 |
| mdprc 184 07 13 001 | Philips Healthcare | CT Scanner, MX8000 IDT 16 Slice CT Scanner | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00747-1 |
| mdprc 065 08 13 000 | Philips Healthcare | Allura Xper FD10 F and Allura FD10/10 | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00813-1 |
| mdprc 064 08 13 000 | HemoCue A B | HemoCue Glucose 201 RT Microcuvettes | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00782-1 |
| mdprc 063 08 13 000 | CSL Behring | Phenocell C 0.8% and Phenocell C 3% | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00829-1 |
| mdprc 055 08 13 000 | Synthes Inc | Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve (PRV) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00451-1 |
| mdprc 135 07 13 001 | Medtronic Inc | Mullins Transseptal Catheter Introducer 7 French Sheath | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00715-1 |
| mdprc 047 08 13 000 | AIMEDICS Pty Ltd | HypoMon Alarm System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00755-1 |
| mdprc 046 08 13 000 | GE Healthcare | ViewPoint including OB Pro-Expert Reporting | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00812-1 |
| mdprc 045 08 13 000 | The Anspach Effort, Inc. | Endoscopes, rigid, accessories | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00530-1 |
| mdprc 039 08 13 000 | Siemens Healthcare Diagnostics | ADVIA Centaur Folate ReadyPack | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00778-1 |
| mdprc 038 08 13 000 | Oxoid Ltd | Oxoid Antimicrobial Susceptibility Testing Discs | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00776-1 |
| mdprc 036 08 13 000 | Medtronic Xomed Inc | Medtronic Xomed Instrument Trays | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00781-1 |
| mdprc 035 08 13 000 | FUJIFILM Medical Systems | FujiFilm Digital Mammography System AMULET (FDR MS-1000) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00768-1 |
| mdprc 033 08 13 000 | Edwards Lifesciences | Shunts, Pulmonary Artery, Anastaflo Intravascular Shunts | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00810-1 |
| mdprc 032 08 13 000 | Cell Marque Corporation | Cell Marque CDX-2 (EPR2864Y*) antibody 7ml | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00776-1 |
| mdprc 199 07 13 000 | Steris Corp | Ultra Concentrate Alkaline Detergent, 5L and 10L Prolystica | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00570-1 |
| mdprc 196 07 13 000 | SGM Biomedical Incorporated | Biological Indicators, EZTest steam and Smart-Read EZTest steam | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00589-1 |
| mdprc 195 07 13 000 | SIEMENS | Biograph mCT PET-CT Systems with VG40A Software | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00623-1 |
| mdprc 194 07 13 000 | Siemens Healthcare Diagnostics | Clinical chemistry analyser, Dimension Vista RF Flex Reagent Cartridge | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00750-1 |
| mdprc 193 07 13 000 | Philips Healthcare | Computed Tomography, Brilliance iCT and iCT SP | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00766-1 |
| mdprc 190 07 13 000 | Livingstone International Pty Ltd | Sterile Disposable Syringe 3mL - Luer Slip | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00739-1 |
| mdprc 189 07 13 000 | HemoCue A B | HemoCue Urine Albumin Microcuvettes | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00753-1 |
| mdprc 188 07 13 000 | Arjo Huntleigh - electric beds | Contoura 380 and 480 Bed | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00762-1 |
| mdprc 058 07 13 001 | Edwards Lifesciences | Rigid Suction Wands | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00675-1 |
| mdprc 147 07 13 001 | BrainLAB | Frameless SRS QA Target Pointer(used with Brainlab Sterotactic System) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00716-1 |
| mdprc 150 07 13 000 | RaySearch Laboratories AB | Radiation therapy treatment planning system, Raystation | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00734-1 |
| mdprc 149 07 13 000 | Baxter Healthcare | Clearlink System Solution Set | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00741-1 |
| mdprc 148 07 13 000 | Atrium Medical Corporation | PTFE Grafts, ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00737-1 |
| mdprc 146 07 13 000 | Medrad Inc | Medrad Hand Controller Sheaths | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00619-1 |
| mdprc 145 07 13 000 | Synthes Inc | Locking Screw Stardrive 2.4mm and 2.7mm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00704-1 |
| mdprc 114 07 13 000 | Pyramed Pty Ltd | Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00615-1 |
| mdprc 113 07 13 000 | Ormco Corp | Mini RPE Screw Assembly (Orthodontic Appliance System) , Mandibular Anterior Repositioning Appliance (M.A.R.A.) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00614-1 |
| mdprc 111 07 13 000 | B Braun Medical Inc | Cementless Columbus Knee System | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00637-1 |
| mdprc 105 07 13 000 | Medline Industries Inc | Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand) | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00706-1 |
| mdprc 104 07 13 000 | CareFusion | Infusion Pumps, Multitherapy, Alaris PC Unit | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00707-1 |
| mdprc 088 07 13 000 | DiaSorin Inc | IVD: viral microbiology instrumentation, Liaison Control Mumps IgG | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00697-1 |
| mdprc 074 07 13 000 | Siemens Healthcare Diagnostics | Buffers, Supplements, Reagesnts , ADVIA Centaur Homocysteine Diluent | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00672-1 |
| mdprc 059 07 13 001 | BrainLAB | Radiotherapy ,iPlan RT system | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00687-1 |
| mdprc 060 07 13 000 | AirSep Corporation | Oxygen Conserver device, AirSep Impulse Elite | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00462-1 |