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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Competent Authorities Composite Listing
TGA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 001 10 23 000ICU Medical, IncPlum 360 Infusion System https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00607-1
mdprc 004 09 23 000Shenzhen Mindray Bio-medical Electronics Co., Ltd,SV600/800 Mindray Ventilatorhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00730-1
mdprc 002 09 23 000Siemens Medical SolutionsACUSON Redwood 2.0 ultrasound systems - 18L6 transducerTGA
mdprc 039 08 23 000Ortho-Clinical DiagnosticsORTHO 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 000Instrumentation Laboratory SpA, a Werfen CompanyACL TOP https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00591-1
mdprc 011 08 23 000Draeger Medical Systems IncBabyleo TN500 IncuWarmerhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00352-1
mdprc 016 10 22 001Siemens Healthcare Diagnostics GmbHAtellica CH 930 Analyzer, Lithium and Lithium_2BfArM
mdprc 002 08 23 000Bio-Rad Laboratories IncLiquichek Pediatric Control. https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00649-1
mdprc 029 07 23 000Ventana Medical SystemsUltraView Universal AP Red Detection Kithttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00561-1
mdprc 033 03 22 001Atrium Medical CorporationAtrium Advanta V12 Covered Stent Systemhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00419-1
mdprc 039 06 23 000Johnson & Johnson Surgical Vision, Inc.VERITAS Advanced Infusion and Fluidics Packshttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00519-1
mdprc 019 06 23 001Shimadzu Corporation..Shimadzu X-Ray system - X-Ray tube support, ceiling mounted CH-200/CH-200MTGA, NCMDR
mdprc 034 06 23 000GS Elektromedizinische Geräte G. Stemple GmbHCorpuls3 Softwarehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00309-1
mdprc 030 05 23 000Biocartis NV.BRAF Mutation Assayhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00328-1
mdprc 009 03 23 000SebiaCAPILLARYS 3 TERA, CAPILLARYS 3 OCTAhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01399-1
mdprc 029 11 22 001SIEMENSSyngo.via with VB20, VB30, VB40, VB60 and VB70 softwarehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00043-1
mdprc 006 01 23 000Agilent Technologies, Inc.Dako CoverStainer CS10030https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01581-1
mdprc 044 12 22 000AGFA Corp.Enterprise Imaging XERO Viewerhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01511-1
mdprc 040 12 22 000Philips HealthcarePhilips 12-Lead Chest Lead-sethttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01345-1
mdprc 013 12 22 000DiaMed GmbH.ID-DiaPanelhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01445-1
mdprc 008 12 22 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostic Products Intact PTH Reagent Packhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01472-1
mdprc 007 12 22 000OlympusEndoeye Flex 3d Deflectable Videoscope, LTF-190-10-3Dhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01441-1
mdprc 006 12 22 000SIEMENSSensis, Sensis Vibe Hemo, Sensis Vibe Combohttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01459-1
mdprc 026 10 22 000FUJIFILM Medical SystemsSynapse PACS Version 5.xhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01311-1
mdprc 020 10 22 001Phadia LtdImmunoCAP Allergen f76.https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01308-1
mdprc 014 10 22 000CepheidXpert EVhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01236-1
mdprc 005 10 22 000ZOLL Medical CorpLi-ion Battery Model 100 (AutoPulse brand) used with ZOLL’s AutoPulse Resuscitation Systemhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01270-1
mdprc 007 03 22 001SIEMENSARTIS icono biplane, ARTIS icono floor, and ARTIS pheno Systems with syngo Application Softwarehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=194235
mdprc 009 09 22 000Siemens Healthcare Diagnostics GmbHDimension 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 000bioMerieux IncVIDAS 3 systemhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01198-1
mdprc 006 09 22 000SIEMENSArtis systemTGA
mdprc 004 08 22 000SIEMENSAXIOM Sensis XP, Sensis / Sensis Lite or Sensis Vibe Combohttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00969-1
mdprc 032 07 22 000Smiths Medical International LimitedLevel 1 Fast Fluid Flow Fluid Warmershttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00850-1
mdprc 026 07 22 000Tandem Diabetes Care, Inct:slim X2 Insulin Pumphttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00627-1
mdprc 008 07 22 0003Shape Medical A/S.3Shape Implant Studio softwarehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00835-1
mdprc 007 07 22 000DiaMed GmbH.ID-DiaPanel Plus 6https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00844-1
mdprc 006 07 22 000Sysmex Corporation JapanSP-50 slidemaker-stainerhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00724-1
mdprc 029 06 22 000Randox Laboratories Ltd.Calibration Serum Level 3https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00817-1
mdprc 018 06 22 000Draeger Medical Systems IncBiliLux - Spring Armhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00722-1
mdprc 011 06 22 000SIEMENSYsio systems with VC10 softwarehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00228-1
mdprc 009 06 22 000Radiometer MedicalABL800 Basic and ABL8XX FLEXhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00710-1
mdprc 008 06 22 000Acutronic Medical Systems AG.fabian HFOi ventilators with software version older than 5.2.1https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00569-1
mdprc 014 12 20 001Siemens Healthcare Diagnostics GmbHADVIA 1800 Chemistry System, ADVIA 2400 Chemistry System, ADVIA Chemistry XPT and Atellica CH 930 Analyzer - Gamma-Glutamyl Transferasehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01244-1
mdprc 012 04 22 000bioMerieux IncVITEK 2 GP ID Test Kithttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00418-1
mdprc 053 03 22 000Philips HealthcarePhilips CombiDiagnost R90 and ProxiDiagnost N90 Systems with software version 1.1.1 or higherhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00344-1
mdprc 051 03 22 000Siemens Healthcare DiagnosticsAtellica UAS 800 Urine Sediment Analyser and Atellica 1500 Automated Urinalysis Systemhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00411-1
mdprc 035 03 22 000VOLCANO CORPORATIONIntraSight IVUS Systemshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00490-1
mdprc 032 03 22 000Siemens Healthcare Diagnostics ProductHuman Chorionic Gonadotropin (HCG) IVDhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00341-1
mdprc 016 03 22 000Siemens Healthcare Diagnostics GmbHVarious Assays on Atellica CH 930 Analyzershttps://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 000Pulsion Medical SystemsPiCCO Monitoring Kit, 150cm line 5/pkghttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00264-1
mdprc 022 02 22 000Instrumentation Laboratory SpAHemosIL AcuStar ADAMTS13 Activityhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00266-1
mdprc 018 01 22 001Philips HealthcarePhilips Fetal Spiral ElectrodeTGA, NCMDR
mdprc 009 01 22 000Shimadzu CorporationShimadzu Sonialvision G4 and Sonialvision Safire 17https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02429-1
mdprc 007 01 22 000Bio Rad.Trimethoprim Sulfametoxazole 1.25-23.75 µg diskhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02418-1
mdprc 003 01 22 000Phadia LtdImmunoCAP Total IgE, ImmunoCAP Specific IgE and ViewAllergyhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02361-1
mdprc 022 12 21 000Draeger Medical Systems IncPerseus A500 Anesthesia workstation ceiling mounted versionhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02378-1
mdprc 021 12 21 000Draeger Medical Systems IncBabyleo TN500 IncuWarmerhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02270-1
mdprc 033 11 21 001AMO Manufacturing USA, LLCCATALYS Precision Laser System and iDESIGN Refractive StudioTGA, Swissmedic
mdprc 001 12 21 000OlympusTJF-Q180V duodenoscopeshttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02057-1
mdprc 018 11 21 000Bio Rad.BioPlex 2200 APLS IgM and BioPlex 2200 APLS IgAhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02166-1
mdprc 009 11 21 000The Binding SiteFreelite 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 000Beckman CoulterDxC AU Glucose Reagenthttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02053-1
mdprc 025 09 21 000Beckman CoulterInorganic Phosphorushttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01795-1
mdprc 010 09 21 000Bio Rad.VIROTROL ToRCH-Mhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01657-1
mdprc 039 08 21 000Draeger Medical Systems IncBabylog VN500, Evita V300 and Evita V500https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01771-1
mdprc 027 08 21 000LiNA MedicalLina Xcise Laparoscopic Morcellator.https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2021-RN-01568-1
mdprc 017 05 20 001Beckman CoulterAccess hsTnI ReagentNCMDR
mdprc 018 08 21 000OlympusCV-1500 Processor, CF-EZ1500DI Colonovideoscope, CF-EZ1500DL Colonovideoscope and GIF-EZ1500 Gastrointestinal Videoscopehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01549-1
mdprc 032 07 21 000Randox Laboratories Ltd.Copper CU2340 R1a Bufferhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01563-1
mdprc 015 07 21 000Gyrus ACMITFL-PLS SOLTIVE Premium SuperPulsed Laser Systemhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01424-1
mdprc 036 12 20 002Radiometer MedicalAll AQT90 FLEX analyzers with serial numbers of 393-838R0564 onwards and all E3800 spare part CPU units, 910-415BfArM
mdprc 005 07 21 001Sony corporation4K LCD Monitorhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01440-1
mdprc 008 07 21 000Randox Laboratories Ltd.Randox Zinc (Zn) Assayhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01451-1
mdprc 002 07 21 000Ortho-Clinical DiagnosticsORTHO VISION Analyzer for BioVue and ORTHO VISION Max Analyzer for BioVuehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01408-1
mdprc 046 06 21 000OrganOX LimitedOrganOx metra Retained Unithttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01412-1
mdprc 044 06 21 000Verathon IncGlideScope Go Video Monitorshttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01343-1
mdprc 040 06 21 000Merit Medical Systems IncbasixALPHA Inflation Devicehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01380-1
mdprc 039 06 21 000Beckman CoulterAccess CEA Reagenthttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01329-1
mdprc 032 06 21 000Siemens Healthcare Diagnostics GmbHAtellica CH 930 Analyser, Atellica IM 1300 Analyser and Atellica IM 1600 Analyserhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01278-1
mdprc 011 06 21 000Siemens Healthcare DiagnosticsAtellica UAS 800 Urine Sediment Analyser and Atellica 1500 Automated Urinalysis Systemhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01232-1
mdprc 016 05 21 000Beckman CoulterAccess Sensitive Estradiolhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01015-1
mdprc 009 05 21 000Beckman CoulterAccess 25(OH) Vitamin D Total for use in Access 2 and DxI Immunoassay systemshttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00958-1
mdprc 008 05 21 000Beckman CoulterAccess Sensitive Estradiolhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00961-1
mdprc 001 05 21 000Welch Allyn, IncGS777 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 000SIEMENSsyngo.via software VB30 versionhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00973-1
mdprc 027 04 21 000Draeger Medical Systems IncDräger Ventilatorshttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00964-1
mdprc 019 04 21 000Dentsply Sirona, IncThe Intego/Intego Prohttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00985-1
mdprc 044 03 21 000Beckman CoulterIMMAGE Immunochemistry Systemshttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00705-1
mdprc 039 03 21 000Medtronic SAEnhanced 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 000Medtronic SAVenaSeal Closure Systemhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00788-1
mdprc 037 03 21 000Siemens Healthcare Diagnostics ProductAtellica NEPH 630 System 1.1 and BN ProSpec System 1.4.3https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00646-1
mdprc 005 02 21 002bioMerieux IncVIDAS CVM IgM.TGA, Swissmedic
mdprc 029 03 21 000Merit Medical Systems IncMerit Medical Surgical Procedure Kits containing BD Syringes and Needleshttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00425-1
mdprc 021 03 21 000Medtronic SAHeartware HVAD Systemhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00572-1
mdprc 007 06 20 001Siemens Healthcare Diagnostics GmbHAtellica IM 1300 Analyser / Atellica IM 1600 AnalyserTGA, Swissmedic
mdprc 020 02 21 000SIEMENSsyngo.via software update VB20Ahttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00360-1
mdprc 018 02 21 000Siemens Healthcare Diagnostics GmbHDimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex Reagent Cartridgehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00323-1
mdprc 015 02 21 000SIEMENSSOMATOM CT scanners running on syngo CT VB20A_SP3https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00352-1
mdprc 002 02 21 000Siemens Medical SolutionsSyngo.via all systems with software version VB40A or VB40Bhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2021-RN-00053-1
mdprc 001 02 21 000CERNER CORPORATIONFetaLinkhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00187-1
mdprc 023 01 21 000Siemens Healthcare Diagnostics IncAtellica 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 000Boston ScientificSingle-Use Polypectomy Snares: Captivator, Captivator II, Captiflex, and Sensationhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2021-RN-00154-1
mdprc 004 02 20 003Siemens Healthcare Diagnostics IncAtellica CH Reaction Cuvette SegmentSwissmedic
mdprc 005 01 21 000Becton Dickinson & Co. (BD)Alaris GP Volumetric Pump with Plus softwarehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01389-1
mdprc 051 05 19 001Medtronic 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 000Terumo BCT IncSpectra Optia Apheresis Systemhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01359-1
mdprc 010 11 20 000Philips HealthcarePhilips V60 Ventilatorhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01040-1
mdprc 009 11 20 000Siemens Healthcare Diagnostics GmbHAtellica IM 1300 and 1600 Analyserhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01067-1
mdprc 002 11 20 000Ortho-Clinical DiagnosticsVITROS 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 000SLESLE4000 & SLE5000 – Control Monitor Boardshttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00916-1
mdprc 014 10 20 000GS Elektromedizinische Geräte G. Stemple GmbHCorpuls3 deviceshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00812-1
mdprc 003 10 20 000W.L. Gore & Associates Inc.GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL Systemhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00847-1
mdprc 037 09 20 000Kowa Company, Ltd.Kowa VK-2s Kowa Retinal Camerahttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00846-1
mdprc 035 09 20 000SIEMENSSOMATOM Definition AS (Family), Definition Edge & Definition Flashhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00836-1
mdprc 016 05 20 001Beckman CoulterIMMAGE Immunochemistry SystemsNCMDR
mdprc 018 09 20 000Dako Denmark A/SDako Autostainerhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00790-1
mdprc 017 09 20 000Inpeco S.A .Aptio Automationhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00778-1
mdprc 005 09 20 000SIEMENSsyngo.plaza VB30A, VB30B and VB30Chttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00726-1
mdprc 018 01 20 001StrykerLIFEPAK 15 Monitor/DefibrillatorTGA, Swissmedic
mdprc 012 08 20 000Philips HealthcarePhilips 3.7V Rechargeable Li-Polymer Battery for Expression MR400 MRI Patient Monitoring System Moduleshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00565-1
mdprc 004 08 20 000WASSENBURG Medical B.V.Wassenburg Dryer320http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00248-1
mdprc 017 07 20 000FUJIFILM Medical SystemsFUJIFILM Synapse PACS Version 5.5.x and 5.7.xhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00544-1
mdprc 041 06 20 000Philips HealthcarePhilips M3015A Microstream CO2 Extensionhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00462-1
mdprc 040 06 20 000Philips HealthcarePhilips 866173 IntelliVue G7m Anaesthesia Gas Moduleshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00516-1
mdprc 039 06 20 000Johnson & Johnson Medical GmbHVirgin Silk Suturehttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00511-1
mdprc 015 12 19 002ResMed Limited.Stellar 100 and 150 Portable VentilatorsNCMDR
mdprc 022 06 20 000Siemens Healthcare Diagnostics ProductIMMULITE 2000 Immunoassay System and IMMULITE 2000 XPi Immunoassay System Waste Bottle Flexible Tubehttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00448-1
mdprc 019 06 20 000Beckman CoulterAccess Sensitive Estradiol Calibratorshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00382-1
mdprc 049 11 19 002Tornier IncAequalis Ascend Flex Stem Implantshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01666-1
mdprc 015 05 20 000Philips HealthcareBrilliance 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 000Beckman Coulterß-2 Microglobulinhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00368-1
mdprc 090 05 19 001Beckman Coulter UK LtdPower Express Sample Processing Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=179661
mdprc 015 04 20 000Siemens Healthcare Diagnostics GmbHADVIA Chemistry Systems 1800/2400/XPT & Atellica CH 930 Analyserhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00308-1
mdprc 012 04 20 000Medtronic 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 001Baxter HealthcareAK 98 Hemodialysis Devices NCMDR
mdprc 029 03 20 000Siemens Healthcare Diagnostics GmbHAtellica CH 930 Analyserhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00218-1
mdprc 019 03 20 000Establishment Labs S.A.Motiva Sterile Silicone Breast Implantshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00078-1
mdprc 017 03 20 000POLYTECH Health & Aesthetic GmbHPOLYTECH Breast Implantshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00187-1
mdprc 015 03 20 000Siemens Healthcare Diagnostics GmbHDimension Total Bilirubin (TBI) Flex reagent cartridgehttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00178-1
mdprc 003 03 20 000Siemens Healthcare Diagnostics GmbHDimension Vista Total Bilirubin (TBIL) Flex reagent cartridgehttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00177-1
mdprc 002 03 20 000Siemens Healthcare Diagnostics GmbHAtellica CH Direct Bilirubin (DBil_2) and Total Bilirubin (TBil_2) Assayshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00176-1
mdprc 001 03 20 000Siemens Healthcare Diagnostics GmbHADVIA Chemistry Direct Bilirubin (DBIL_2) and Total Bilirubin (TBIL_2) Assayshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00175-1
mdprc 029 02 20 000Biocartis 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 000Siemens Healthcare Diagnostics GmbHAtellica CH Ethyl Alcohol (ETOH)http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00179-1
mdprc 011 02 20 000Medtronic McGrath X3 Disposable Laryngoscope Bladeshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00139-1
mdprc 013 11 19 001Dako Denmark A/SDako Autostainer Syringe Trayhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01614-1
mdprc 023 01 20 000DNA Genotek Inc.Oragene DNAhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01839-1
mdprc 022 01 20 000Siemens Healthcare Diagnostics GmbHAtellica IM Humidity Packhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00015-1
mdprc 020 01 20 000SIEMENSVarious Cios Systemshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00032-1
mdprc 027 05 19 001C R Bard Inc.EnCor Breast Biopsy ProbesNCMDR
mdprc 008 01 20 000Bedfont Scientific Limited‘FeNOBreath’, Factional Exhaled Nitric Oxidehttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01879-1
mdprc 035 11 19 001MAQUET Cardiopulmonary GmbHQUADROX-iD Paediatric with BIOLINE Coatinghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=178112
mdprc 044 12 19 000Siemens Healthcare Diagnostics Inc Atellica IM NT-proBNP (PBNP) 100 Test Kit and 500 Test Kithttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01869-1
mdprc 032 12 19 000Linet spol. s r.o.Eleganza 5 Bedshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01675-1
mdprc 013 12 19 000Philips HealthcareXper Information Management System version 2.4.2 and 2.4.3http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01686-1
mdprc 034 11 19 000Nagor LimitedTextured Nagor GFX, CoGel and Impleo Mammary Implantshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01488-1
mdprc 032 11 19 000Human Meditek CO., LTDHMTS 142D Plasma Sterilisershttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01615-1
mdprc 031 11 19 000Beckman CoulteriChemVELOCITY Urine Chemistry Systemhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01654-1
mdprc 025 11 19 001bioMerieux IncBACT/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 000Draeger Medical Systems IncOxylog 3000 Transport Ventilatorshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01618-1
mdprc 017 11 19 000Siemens Healthcare Diagnostics GmbHAtellica IM Testosterone II 100 and 500 Test Kitshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01637-1
mdprc 009 11 19 000StrykerInTouch Critical Care Bedhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01590-1
mdprc 005 11 19 001Bard Peripheral Vascular Inc Max-Core Disposable Core Biopsy Instrumentshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01585-1
mdprc 004 11 19 000POLYTECH Health & Aesthetic GmbHSublime Line, Microthane & 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implantshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01485-1
mdprc 003 11 19 000Haemonetics 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 001Baxter HealthcareArtiset Blood Tubing System NCMDR
mdprc 001 11 19 000GE HealthcareCARESCAPE Respiratory Moduleshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01494-1
mdprc 087 02 19 003OlympusOlympus Duodenovideoscope NCMDR
mdprc 038 10 19 000Roche Diagnostics CorpHomocysteinehttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01511-1
mdprc 030 10 19 000Beckman CoulterUniCel 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 000Baxter HealthcarePrismaflex Control Units with software versions 7.20 and belowhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01484-1
mdprc 013 10 19 000Beckman CoulteriChemVELOCITY Urine Chemistry Stripshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2019-RN-01469-1
mdprc 116 09 19 001MAQUET 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 000Siemens 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 000Randox 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 000Merit 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 000Ga 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 000Draeger Medical Systems IncIACS 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 000Steelco SpA.Steelco Endoscope Dryers http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01092-1
mdprc 143 09 19 000Signature OrthopaedicsATOK Shoulder Anchor http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01401-1
mdprc 105 07 19 001Terumo BCT IncSpectra Optia Apheresis System NCMDR
mdprc 129 09 19 000Zimmer, INCROSA Brain 3.0 Surgical Systemshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01391-1
mdprc 128 09 19 000Philips HealthcarePhilips 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 000GN ReSound A/SSelected Behind-the-Ear hearing aidshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01393-1
mdprc 118 09 19 000OriGen BiomedicalOriGen 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 000Medifab Medical FabricationShuttle 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 000MAQUET 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 000CODAN 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 000Candela CorporationGentleCool Pro Cryogen Canister http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01359-1
mdprc 069 01 19 003Medtronic Adapta Dual Chamber Pacemakers NCMDR
mdprc 105 09 19 000Serres OySerres Suction Bag Liner http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01323-1
mdprc 104 09 19 000Electromedical Products InternationalAlpha Conducting Solution used with Alpha-Stim M & AID deviceshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01314-1
mdprc 103 09 19 000Codman & Shurtleff IncCerelink ICP Monitor http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01354-1
mdprc 102 09 19 000Beckman CoulterSYNCHRON 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 000Beckman CoulterIMMAGE 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 000Beckman CoulterSYNCHRON 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 000B Braun Medical IncIntrocan Safety IV Catheter http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01289-1
mdprc 062 09 19 001ZimmerVanguard XP-CR Tibial Tray https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175837
mdprc 007 08 19 001Cincinnati 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 000LabStyle Innovations LtdDario Blood Glucose Tracker app http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01322-1
mdprc 081 09 19 000ConvaTecVarious 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 001BD BiosciencesBD FACSLyric Flow Cytometer http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01243-1
mdprc 061 09 19 000Prima Medical LtdPrima 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 000Howmedica 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 000Briggs HealthcareTheraBead 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 000Vyaire 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 000Siemens 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 000Rocket MedicalRocket FBS Amnioscopes http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01188-1
mdprc 054 09 19 000Roche 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 000Mavidon Medical ProductsLemonPrep 114gm tubes http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01158-1
mdprc 052 09 19 000Inomed Medizintechnik GmbHC3 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 000Beckman CoulterREMISOL Advance http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01275-1
mdprc 050 09 19 000Beckman CoulterVarious Assays http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01286-1
mdprc 049 09 19 000Argon Medical DevicesArterial 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 000Alcove 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 000Corin LimitedMetafix stem size 4 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01151-1
mdprc 019 09 19 000WeinmannWeinmann Adult MEDUCORE Multifunctional Electrodeshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01173-1
mdprc 018 09 19 000Beckman CoulterSYNCHRON Systems Benzodiazepine (BNZG) Reagent http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01194-1
mdprc 016 09 19 000ICU 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 000Ad-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 001MAQUET 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 000LimacorporateModulus, 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 001Medtronic BIS Vista and BIS View Monitoring SystemsNCMDR
mdprc 012 07 19 001Varian Medical SystemsStainless 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 001Biomet 3i Inc. 3.4mm Certain BellaTek Abutment, ILDAT3https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171233
mdprc 089 05 19 001Apollo 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 000SIEMENSMAMMOMAT 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 000Mesa 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 000Allergan services international LimitedTextured Breast Implants and Tissue Expandershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01116-1
mdprc 115 07 19 000Henry 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 000SIEMENSSOMATOM 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 000SIEMENSBiograph 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 000Medicrea International.PEEK Cervical Cages and PEEK Lumbar Cageshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01105-1
mdprc 101 07 19 000Cooper 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 000SPIGGLE & THEIS MedizintechnikPanetti ENT endoscopic ear instrumentshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01102-1
mdprc 096 07 19 000Radiometer America IncRadiometer 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 000GE HealthcareFluorostar 7900 System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01085-1
mdprc 076 07 19 000HEIDELBERG ENGINEERING GmbHHEYEX 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 000Phadia LtdImmunoCAP Tryptase Control http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01091-1
mdprc 074 07 19 000QIAGEN LtdQIAsymphony 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 001BioFire Diagnostics Inc.FilmArray Gastrointestinal (GI) Panel.NCMDR
mdprc 064 07 19 000Getinge GETINGE Steam Steriliser http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01071-1
mdprc 043 07 19 000Phadia LtdPhadia 1000 instrument http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01055-1
mdprc 042 07 19 000Morcher GmbHMorcher 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 000BD BiosciencesBD 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 000GE HealthcareMAC VU360 systems http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01054-1
mdprc 026 07 19 000Nuvasive 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 000Cyclomedica Australia Pty LtdTechnegasPlus Generator http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01023-1
mdprc 058 05 19 001Siemens 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 000Beckman CoulterAQUIOS IMMUNO-TROL Low Cells http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01033-1
mdprc 037 05 19 001Baxter HealthcarePrismaflex 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 000Medical Innovation Developpement SASMID-Tube, Orogastric calibration Tubehttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00985-1
mdprc 089 06 19 000Arjo HuntleighTenor Passive Floor Lifthttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00978-1
mdprc 018 06 19 001Teleflex MedicalSheridan Endotracheal Tubeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173225
mdprc 069 06 19 000RSR LtdACHRAb RIA kits. http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00918-1
mdprc 068 06 19 000ZimmerComprehensive Reverse Shoulder Instrument Caseshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00922-1
mdprc 050 06 19 001Becton Dickinson & Co. (BD)Microtainer TubesSwissmedic
mdprc 053 06 19 000Terumo BCT IncSpectra Optia Apheresis System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00878-1
mdprc 052 06 19 000Randox 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 000Magic MobilityMagic mobility wheelchair - Mobility Handles http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00907-1
mdprc 049 06 19 000Beckman CoulterSYNCHRON Systems Phosphorus Reagent (PHOSm) http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00916-1
mdprc 083 04 19 001Accuray 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 000QIAGEN LtdFilter-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 000Philips HealthcarePhilips 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 000CODAN Medizinische Geraete GmbH & Co KGCodan Extension Set https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00813-1
mdprc 014 06 19 000Nanjing 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 000Pride Mobility Products LtdJ623 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 000Beckman Coulter UK LtdUniCel 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 001Beckman Coulter Inc..UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171361
mdprc 114 05 19 000Aidacare Pty LtdTilt & 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 000GE HealthcareLVivo 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 000Nidek 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 000SIEMENSMAGNETOM 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 001Integra LifeSciencesLimiTorr Volume Limiting External CSF Drainage and Monitoring Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172225
mdprc 092 05 19 000Change HealthcareMcKesson Cardiology Hemo Systemshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00745-1
mdprc 091 05 19 000MedicinaENFit 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 000Ivor Shaw Limited As Peninne HealthcareVarious Gastric Tubes and Catheters https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00746-1
mdprc 059 05 19 000Siemens 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 000Medtronic O-Arm 1000 Imaging Systemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00728-1
mdprc 115 04 19 001MacoPharma ACDA Anticoagulant Solution http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00633-1
mdprc 059 08 18 001Air Liquide Medical SystemsMatrx Digital MDM Mixerhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00663-1
mdprc 038 05 19 000MAKO 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 001Boston ScientificAuriga 30 Laser System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00565-1
mdprc 061 04 19 001Arc Laser GmbHWolf 445nmhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00550-1
mdprc 028 05 19 000Edwards LifescienceslntroFlex lntroducers http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00683-1
mdprc 026 05 19 000Beckman CoulterIMMAGE 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 000Sysmex 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 000SIEMENSSOMATOM 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 000Covidien Monoject Standard Hypodermic Needles http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00671-1
mdprc 009 05 19 000ZimmerAlvarado Knee Holder Base Plate Assemblies and Foot Pieces and Alvarado II Base Plates and Foot Pieceshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00660-1
mdprc 146 04 19 000SIEMENSBiograph 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 001Carestream HealthCarestream Onsight 3D Extremity System https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171699
mdprc 084 04 19 001Cook MedicalPericardiocentesis Catheter Set http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00568-1
mdprc 062 04 19 001Beaver Visitec International LtdVisiwipe Instrument Wipe 73 x 73mmBfArM
mdprc 116 04 19 000Teleflex Medical Rüsch Lasertubeshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00606-1
mdprc 114 04 19 000Istanbul Medikal LtdMedwarm 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 000DiaSorin 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 000Stryker Berchtold CHROMOPHARE F 528 and F 628 Surgical Light System Light Head Covershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00575-1
mdprc 086 04 19 000Oxoid 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 000Direct Healthcare Services LtdMercury Advance V1 Control Unit http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00563-1
mdprc 082 04 19 000AbbottTactiSys Quartz Equipment operating http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00571-1
mdprc 079 04 19 000Cincinnati 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 000Baxter HealthcareMicrobore 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 000Delfi 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 000Welch 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 000Medtronic SADrill Mini-Trephination 2.0mmhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00503-1
mdprc 098 03 19 000Edwards LifesciencesMiller and Fogarty Atrioseptostomy Cathetershttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00499-1
mdprc 087 03 19 000Biomet Spain Orthopaedics SLPolished 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 000Topcon 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 000Alba BioscienceALBAclone Anti-Leb Reagentshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00248-1
mdprc 068 03 19 000Edwards LifesciencesVAMP Optima Blood Sampling System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00433-1
mdprc 067 03 19 000Medtronic 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 000Draeger 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 002Radiometer 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 000bioMerieux 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 000Biocomposites LtdGenex Putty 5cc http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00380-1
mdprc 017 03 19 000Phadia ABImmunoCAP ISAC sIgE 112 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00343-1
mdprc 016 03 19 000Medtronic 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 001Maquet 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 000Varian Medical SystemsVelocity 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 001Baxter HealthcareEXACTAMIX Empty EVA Bagshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00291-1
mdprc 091 02 19 000Ardo medical AGArdo Sterile Tulips Nipple Shields, Medium and Largehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00259-1
mdprc 027 12 18 001Shimadzu Medical Systems.Digital Angiography System Triniashttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170548
mdprc 088 02 19 000SIEMENSMultiple 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 000Medrobotics CorporationObturator, 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 000Beckman Coulter Access Thyroglobulin Antibody II Reagentshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00238-1
mdprc 077 02 19 000Varian Medical SystemsTrueBeam 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 000Stryker Xia 3 Degen Tray and French Bender instrumenthttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00206-1
mdprc 075 02 19 000Shimadzu 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 000Clearstream Technologies LtdBard 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 000Varian Medical SystemsARIA OIS for Radiation Oncology http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00169-1
mdprc 059 02 19 000Randox 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 000Medrad Inc.Radimetrics CDM Software http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00204-1
mdprc 057 02 19 000GE HealthcarePanda 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 001Diagnostica StagoSTA – VWF:RCo reagent http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00119-1
mdprc 033 02 19 000FUJIFILM 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 000Ultradent Products, Inc.UltraTemp & UltraTemp REZhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00120-1
mdprc 027 02 19 000Schulte-ElektronikSISS BABYCONTROL Respiration Monitorshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00055-1
mdprc 026 02 19 000Varian Medical SystemsVariSource HDR and GammaMed http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00140-1
mdprc 025 02 19 000Edwards LifesciencesCommander Delivery Systems.http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00136-1
mdprc 024 02 19 000Varian Medical SystemsARIA Radiation Therapy Management http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00146-1
mdprc 012 02 19 000Applied Medical Resources5x75mm 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 002Medtronic Suction/Anticoagulation Assembly Lineshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169578
mdprc 069 01 18 002Beckman CoulterFC 500 Series Flow CytometersNCMDR
mdprc 130 10 18 001GE HealthcareCARESCAPE R860 Inspiratory Safety GuardNCMDR
mdprc 074 01 19 001bioMerieux Inc.VITEK 2 - Card Pouch Integrity NCMDR
mdprc 079 01 19 000Arthrex, IncBURR 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 000Shaoxing Fuqing Medical Products Co LtdElectronic 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 000Edwards LifesciencesEdwards 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 001Medtronic 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 000Cook 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 001ImmucorPanocell-16 Kit NCMDR
mdprc 014 01 19 000Limacorporate 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 000Agilent Technologies, Inc.Autostainer Slide Rackshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01606-1
mdprc 133 12 18 000Getinge Disinfection ABGETINGE XS32 Flat Screen Holder https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01602-1
mdprc 046 05 17 001Natus 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 000Olympus Winter & IBE GmbHVarious 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 000Medrad 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 000Thermo 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 000Stryker 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 000Stryker CommunicationsStryker 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 001MAKO Surgical CorpMako 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 000Beckman CoulterUniCel 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 000Amplitude 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 000SIEMENSBiograph Horizon http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01547-1
mdprc 075 12 18 000STEELCO Steelco DS1000 washers http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01540-1
mdprc 074 12 18 000Rayner 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 000Novos Medical Systems Industry Trade Import and Export Ltd CoBililed Maxi+ Phototherapy Unit http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01464-1
mdprc 072 12 18 000DePuy 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 000Becton, Dickinson And CompanyBD Burette Sets http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01537-1
mdprc 070 12 18 000B 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 001OlympusOlympus Bronchofiberscopes, Bronchovideoscopes, Bronchofibervideoscopes, Ultrasonic Bronchofibervideoscopes, Rhino-laryngo Videoscopes and Airway MobilescopesNCMDR
mdprc 059 12 18 000Microgenics 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 002Medtronic Medtronic HeartWare HVAD System Battery Charger https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169057
mdprc 028 12 18 000Cis Bio InternationalCisbio - Chromogranin A (CGA-ELISA) http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01522-1
mdprc 026 12 18 000Synovis Micro Companies Alliance Inc. Synovis GEM4183C Coupler Forcepshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01519-1
mdprc 018 12 18 000Hologic Inc.I-View Contrast Enhanced Digital Mammographyhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01515-1
mdprc 017 12 18 000MED-EL Elektro-Medizinische Geraete GmbHSonata ti100 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01511-1
mdprc 016 12 18 000SIEMENSSyngo.plaza version VB30A_HF01 and previous software versionshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01509-1
mdprc 015 12 18 000Stryker NeurovascularBalloon Guide Catheters 9F http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01500-1
mdprc 014 12 18 000Intuitive 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 000Optics MedicalRaindrop Near Vision Inlayshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01465-1
mdprc 001 12 18 000MedicinaMedicina CG Nasogastric Tubes http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01482-1
mdprc 102 11 18 000RaySearch 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 000Eurotrol B.VHemoTrol Hemoglobin Controlshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01436-1
mdprc 072 11 18 000GE HealthcareRevolution CT Systems with SmartStep Optionhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01452-1
mdprc 071 11 18 000House With No StepsFG107 Intravitreal Procedure Pack #1 and FG110 Intravitreal Procedure Pack #2Ahttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01442-1
mdprc 070 11 18 000Misonix, Inc.BoneScalpel and SonaStar FS1000 Ultrasonic Surgical Systemshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01444-1
mdprc 055 11 18 000Diagnostica StagoSTACLOT LA (REF. 00600).NCMDR
mdprc 038 11 18 000Carestream HealthKodak DirectView DR 7500 System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01434-1
mdprc 037 11 18 000Cambridge Nutritional Sciences LtdFoodPrint Microarray 200+ Food IgG.http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01431-1
mdprc 036 11 18 000BioArray 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 000Argon Medical Devices4-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 000Carl Zeiss Plex Elite 9000 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01414-1
mdprc 152 10 18 000BioArray 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 000IRIS DiagnosticsiChemVELOCITY Urine Chemistry strips http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01395-1
mdprc 131 10 18 000bioMerieux 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 000Demeditec Diagnostics GmbHReverse T3 RIA http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01390-1
mdprc 116 10 18 000Siemens HealthcareBiograph mMR with software version syngo E11P when using BodyCOMPASShttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01388-1
mdprc 112 10 18 000ICU 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 mLhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01375-1
mdprc 111 10 18 000Paragon 28, Inc.TITAN 3-D Wedge, Evans, Large, 10mmhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01380-1
mdprc 088 10 18 000LeMaitre 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 000Enterix Pty LtdColoVantage 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 001Orthosensor 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 000Belmont Instrument CorpBuddy Disposable Sets http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01327-1
mdprc 047 10 18 000Datascope CorpCARDIOSAVE Intra-Aortic Balloon Pumpshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01317-1
mdprc 046 10 18 000GE HealthcareLOGIQ 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 000Integra LifeSciencesCUSA 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 000K2M Inc.YUKON OCT Spinal System Polyaxial Screw Size 3.5 x 34mmhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01326-1
mdprc 043 10 18 000RaySearch Laboratories RayStation and RayPlan http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01322-1
mdprc 042 10 18 000Siemens 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 000Siemens Healthcare DiagnosticsRAPIDPoint 500 Blood Gas Systemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01330-1
mdprc 040 10 18 000SIEMENSBiograph 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 001Abbott 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 000Medtronic O-arm O2 Imaging Systemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01313-1
mdprc 030 10 18 000TiSportX-Short anti-tip tubes on certain TiLite manual wheelchairshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01302-1
mdprc 109 08 18 001Bio RadPastorex Meningitis - reagent R4 (Streptococcus pneumoniae latex - green cap bottle).Swissmedic Update
mdprc 088 09 18 000Abbott Laboratories ARCHITECT ICT Moduleshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01256-1
mdprc 086 09 18 000Leica 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 000Samsung ElectronicsSamsung Digital X-Ray System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00982-1
mdprc 084 09 18 000Siemens 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 000Alcon Laboratories Inc.CyPass Micro-Stentshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01228-1
mdprc 080 09 18 000Bio 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 000Bio-Rad Laboratories D-100 Haemoglobin Testing Systemhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01239-1
mdprc 104 08 18 001Siemens 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 000AGFA 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 000CepheidXpert Xpress Flu/RSV assay http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01155-1
mdprc 107 08 18 000CERNERCerner Dosage Calculator used via PowerOrders or Pharmacy Medication Managerhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01060-1
mdprc 106 08 18 000EvolutisBroach Handles for rasp used in orthopaedic surgeryhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01127-1
mdprc 105 08 18 000Permobil 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 000Smiths Medical Jelco ViaValve safety I.V. catheterhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01206-1
mdprc 102 08 18 000Stryker Hoffmann Limb Reconstruction Frame (LRF) System Hexapod Strutshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01203-1
mdprc 101 08 18 000Therakos Inc.Therakos Cellex Photopheresis Systemhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01156-1
mdprc 100 08 18 000TransMedicsOrgan Care System (OCS) Heart system - OCS Heart Consolehttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01113-1
mdprc 099 08 18 000Vision RTAlignRT Plus/OSMS system http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01166-1
mdprc 096 08 18 000Medtronic 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 000SPATZ FGIA, INC..Spatz3 Adjustable Gastric Balloon Systemhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01039-1
mdprc 062 08 18 000Medtronic SACapnostream 20 and Capnostream 20p Bedside Patient Monitorshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01102-1
mdprc 061 08 18 000Medical Components, IncShort Term Haemodialysis Cathetershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01084-1
mdprc 058 08 18 000Stryker EuropeHoffmann LRF Hexapod Software.http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01118-1
mdprc 057 08 18 000Sage In-Vitro Fertilization Inc Various in vitro fertilisation (IVF) and assisted reproduction technologies (ART) productshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00594-1
mdprc 041 08 18 000Medos Medizintechnik AG.Deltastream Heater-Cooler Unithttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00886-1
mdprc 040 08 18 000Elekta IncMOSAIQ Medical Oncology version 2.64 SP3 and higherhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01070-1
mdprc 039 08 18 000Draeger Medical Systems IncDräger Ceiling Supply Unit; AGILA and Movita Lift Pendantshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01066-1
mdprc 037 08 18 000Thermo 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 000Esaote S.p.A.MyLab Alpha in combination with IH 6-18http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01043-1
mdprc 011 03 18 001Natus NeurologyNatus NicoletOne 32Ch Ambulatory EEG Record Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164231
mdprc 116 07 18 000Bio-Rad Laboratories IncIH-Com Fullversion & IH-Com for Readerhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01010-1
mdprc 115 07 18 000Bio-Rad Laboratories IncCFX96-IVD Optical Reaction Modulehttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01004-1
mdprc 102 07 18 000Integra LifeSciencesMAYFIELD Spine Table Adapters and Various Infinity XR2 Base Unitshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00912-1
mdprc 025 07 18 001B Braun Surgical SASafil Sutures http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00737-1
mdprc 070 07 18 000LivaNova 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 000Getinge LancerGETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressorhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00906-1
mdprc 054 07 18 000Elekta Inc.Leksell GammaPlan 11.1http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00844-1
mdprc 053 07 18 000Medtronic Guardian Connect Mobile App http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00882-1
mdprc 052 07 18 000Olympus10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescopehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00841-1
mdprc 051 07 18 000Philips HealthcarePatient Supports for Stitching http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00881-1
mdprc 050 07 18 000Vygon 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 000VygonPremicath Neonatal PICC with Stylethttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00478-1
mdprc 026 07 18 000Ambu AMBU Ultraseal II Anaesthetic Maskhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00799-1
mdprc 024 07 18 000Baxter In-Line Blood Set with Filterhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00783-1
mdprc 023 07 18 000FUJIFILM Synapse Cardiovascular (CV) Software http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00504-1
mdprc 022 07 18 000Natus Medical Xltek NeuroWorks Softwarehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00575-1
mdprc 021 07 18 000NeoMed Inc. NeoMed Enteral Feeding Tubes with EO Connectorshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00734-1
mdprc 020 07 18 000NxStage Medical, Inc.NxStage Express Fluid Warmerhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00798-1
mdprc 019 07 18 000Starkey LaboratoriesEarmoulds in use with children under 36 monthshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00474-1
mdprc 018 07 18 000Sunrise MedicalZippie Zone Wheelchairhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00160-1
mdprc 007 07 18 000Stryker Leibinger GmbH & Co.KGQuikFlap Neuro Implantshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00682-1
mdprc 006 07 18 000Zimmer Surgical Inc.Dermatome ANhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00745-1
mdprc 063 06 17 001Roche Diagnostics Corpcobas 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 000QIAGEN LtdEZ1 DSP Virus Kit (48) http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00659-1
mdprc 049 06 18 000Medtronic SAStraightShot Microdebrider Blades http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00675-1
mdprc 048 06 18 000MAQUET IncVOLISTA 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 000Baxter HealthcareFLOSEAL Special Applicator Tipshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00670-1
mdprc 046 06 18 000SIEMENSSymbia 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 001Radiometer 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 000Stryker OrthopaedicsLFIT V40 Femoral Heads ..http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00639-1
mdprc 124 05 18 000BioArray 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 000Biomet 3i Inc. Tapered Screw-Vent Implants with 0.5 mm Machined Collar, MTX Surface and Microgrooveshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00509-1
mdprc 122 05 18 000Phoenix SrlArcomed Volumed Set for Pump Type Volumed µVP 5005/7000 PVC and Gravity Usehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00367-1
mdprc 121 05 18 000Remel Inc.R30855101 - Salmonella paratyphi A-H Stained Suspension.Medical supplies & Services Co.Ltd Mediserv
mdprc 114 06 16 001ConMed CorporationCORE Suction Irrigation Handpieces http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00844-1
mdprc 084 05 18 000Medtronic Clip Gun Magazineshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00488-1
mdprc 065 05 18 000Roche 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 000Oxoid 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 000O-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 000Ethicon 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 000Dräger Dräger Carina Ventilator http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00394-1
mdprc 012 05 18 000Carl Zeiss CLARUS 500http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00350-1
mdprc 154 04 18 000FUJIFILM CorporationFUJIFILM General X-ray System FDR Smart f serieshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00351-1
mdprc 153 04 18 000MedicinaMedicina Nasogastric Tubeshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00269-1
mdprc 152 04 18 000TriMed Nitinol Staples / Elastic Staples - Large and Small Symmetricalhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00354-1
mdprc 151 04 18 000Wright 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 000Stryker MedtechSonopet Ultrasonic Products http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00323-1
mdprc 100 04 18 000Gyrus ACMIClassic 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 000Edwards LifesciencesIntraClude Intra-aortic Occlusion Device http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00313-1
mdprc 091 04 18 000Phadia ABEliA Intrinsic Factor Well http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00317-1
mdprc 090 04 18 000Philips HealthcarePhilips Ingenuity Core (728321)http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00312-1
mdprc 058 03 17 001CareFusion 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 001Medtronic MindFrame Capture LP Deviceshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00194-2
mdprc 020 04 18 000Getinge Sterilization ABGetinge Sterilizer http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00196-1
mdprc 019 04 18 000Welch 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 002Deerfield ImagingIMRIS ORT100 and ORT300 Operating Room Tableshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162121
mdprc 118 03 18 000Medtronic Covidien LigaSure Exact Dissector Nano-Coated 20.6mm-21cmhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00261-1
mdprc 117 03 18 000Remel 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 000Well Lead Medical Co LtdElongated Adult Non Rebreathe Maskhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00260-1
mdprc 114 03 18 000HemoCue ABHemoCue WBC Diff analysers and WBC Diff Microcuvetteshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00161-1
mdprc 077 03 18 000Philips HealthcareIngenuity 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 000Zimmer Biomet, Inc.EBI OsteoGen Implantable Bone Growth Stimulatorhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00210-1
mdprc 074 03 18 000Intuitive Surgical Inc. da Vinci X Patient Side Cart Arm Controller Joint Circuit Boardshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00231-1
mdprc 073 03 18 000Transonic Systems Inc. ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Sethttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00220-1
mdprc 100 08 17 001Beckman CoulterAQUIOS CL Flow Cytometry System.http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01101-1
mdprc 048 03 18 000Sofradim ProductionVersate Monofilament Mesh, 50x50 cmhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00191-1
mdprc 039 03 18 000EvolutisHACTIV Calcar reamers http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00156-1
mdprc 090 12 17 001Siemens Healthcare DiagnosticsIMMULITE/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 0003M Health Care LtdFuturo Quick Strap Ankle Supporthttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00098-1
mdprc 003 03 18 000Cook MedicalCook Aspiration Unit http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00174-1
mdprc 002 03 18 000Jolife ABLUCAS 2 Chest Compression System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00147-1
mdprc 001 03 18 000Tae-Chang Industrial Co.U-100 Insulin Syringe 0.5mL 27G and 29Ghttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00171-1
mdprc 061 01 18 001Allen Medical SystemsRadiolucent Spine Surgery Framehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00024-1
mdprc 089 02 18 000Arjo Huntleigh Enterprise and Citadel Range Bedshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01199-1
mdprc 088 02 18 000Mathys Ltd BettlachbalanSys UNI convex PE inlay x/6, x/7, x/9http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00096-1
mdprc 086 02 18 000SIEMENSBiograph Horizon with VJ20A Softwarehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00126-1
mdprc 085 02 18 000Southwest TechnologiesHypothermia Caps, Mittens and Slippershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00121-1
mdprc 077 02 18 000SPINEARTSmall 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 000SIEMENSBiograph mMR with software version syngo E11Phttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00113-1
mdprc 075 02 18 000SIEMENSACUSON SC2000 ultrasound systems http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00115-1
mdprc 074 02 18 000MAQUET IncMaquet 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 000Life 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 000Beckman CoulterAutomate 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 000Signature OrthopaedicsSignature Ceramic Femoral Head http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00091-1
mdprc 032 02 18 000Siemens Healthcare DiagnosticsDimension 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 000Medline 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 000Coloplast A/SBiatain Ag Cavity Fillerhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00086-1
mdprc 026 02 18 000Medtronic Valleylab FT10 energy platformhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00094-1
mdprc 001 02 18 000GCMedica Enterprise LtdFraizer suction handlehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00061-1
mdprc 091 05 17 001Zimmer 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 002Greiner Bio-One IncVacuette 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 000QIAGEN Ltdtherascreen 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 000SIEMENSArtis 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 000HOLOGIC Panther and Panther Fusion Systems with 19-in monitorhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00065-1
mdprc 075 01 18 000Moog Inc. Moog Infusion System Administration Setshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00053-1
mdprc 059 01 18 000Ningbo Runyes Medical Instrument Co LtdRunyes Autoclavehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00001-1
mdprc 057 01 18 000Tornier Inc.Multiple Tibial Implants http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00008-1
mdprc 056 01 18 000DePuy 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 000COUSIN BIOTECHNAJA 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 000Beckman CoulterSynchron Enzyme Validator http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00018-1
mdprc 039 01 18 000Salter LabsOxygen Cannulas http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01545-1
mdprc 117 12 17 000Philips HealthcareIngenuity TF PET/CT http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01541-1
mdprc 107 12 17 000BioMerieux 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 000ColoplastRestorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Slinghttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01542-1
mdprc 105 12 17 000Medos International SARLDePuy 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 000SynCardia 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 000BEKA Hospitec GmbHC- Series liftshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01450-1
mdprc 095 12 17 000Boston ScientificNv Guider Catheter 90cmhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01517-1
mdprc 094 12 17 000Boston ScientificUphold 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 000Cook Inc.Transseptal Needle http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01503-1
mdprc 091 12 17 000O-Two Medical Technologies, Inc. Equinox Advantage- Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery Systemhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01485-1
mdprc 050 12 17 000MAKO Surgical CorpMCK 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 000Waverley Glen Systems LtdC-Series Lifts http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01442-1
mdprc 048 12 17 000R & R Healthcare Equipment Pty LtdHercules Patient Lifter http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01492-1
mdprc 046 12 17 000Dako 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 000BioArray Solutions LtdMIA 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 000AirSep CorporationAirsep Impulse Elitehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01448-1
mdprc 022 12 17 000Edwards LifesciencesIntro-Flex Automatic Hemostasis Valve Introducerhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01488-1
mdprc 021 12 17 000Balt ExtrusionBalt Cristal Balloonshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01483-1
mdprc 020 12 17 000Cook MedicalVarious Vital-Port Vascular Access Systemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01453-1
mdprc 019 12 17 000Phadia LtdPhadia Prime with software up to and including version 2.1.4http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01452-1
mdprc 011 12 17 000Intelerad Medical Systems Inc.IntelePACS with software versions 4-3-1 and uphttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01434-1
mdprc 005 12 17 000RaySearch Laboratories ABRayStation and RayPlanhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01436-1
mdprc 012 06 17 001Siemens Healthcare Diagnostics N Antiserum to Human Ceruloplasminhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156195
mdprc 121 11 17 000Beckman Coulter…Remisol Advance Software Versions Used with Abbott Architect Instrumentshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01404-1
mdprc 120 11 17 000Covidien LLCRechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilatorshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01429-1
mdprc 119 11 17 000Global Manufacturing TechnologyGlobal Cup Poly Liner, Neutral prostheseshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01262-1
mdprc 118 11 17 000Implant Direct Sybron Manufacturing,LLCSpectra System/Legacy Guided Surgery Handle Kit Insertshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01423-1
mdprc 117 11 17 000Life Technologies CorporationFoetal 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 000Seqirus Pty LtdEpiclone 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 000Seqirus Pty LtdEpiclone Anti-M Blood Grouping Reagenthttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01361-1
mdprc 114 11 17 000Stryker Howmedica Osteonics CorpMETS Principal Shafthttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01412-1
mdprc 060 11 17 000William Cook Europe ApSDisposable Reuter Tip-Deflecting Wire Guidehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01390-1
mdprc 001 09 14 001Siemens Healthcare Diagnostics GmbHDimension Vista Hemoglobin A1c (HbA1c)http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01393-1
mdprc 059 11 17 000Remel Inc.Thermofisher Remel Bactipstaph Latex Kitshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01410-1
mdprc 058 11 17 000Physio Control IncInfant/Child Reduced Energy Defibrillation Electrodes Used with LIFEPAK Automatic External Defibrillatorshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01389-1
mdprc 057 11 17 000Hill-Rom, Inc. &SubsidiariesCompella Air Surfaces Bed System (220 - 240 V, 50 Hz),Arabian Medical Marketing Co. (AMCO)
mdprc 056 11 17 000Beckman CoulterDxH 500 Open-Vial Haematology Systemhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01401-1
mdprc 055 11 17 000DePuy International LimitedAcetabular Cup Introducerhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01385-1
mdprc 054 11 17 000LivaNova Deutschland GmbH.Sorin Group perfusion system – Heater Cooler 1T deviceshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01370-1
mdprc 053 11 17 000LivaNova Deutschland GmbH.Sorin Group perfusion system – Heater Cooler 3T deviceshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01368-1
mdprc 011 11 17 000Actelion Pharmaceuticals Veletri Consumables Kit with non Flow-Stop CADD Medication Cassette Reservoirshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01369-1
mdprc 010 11 17 000AGFA 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 000Dako Denmark A/SFLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-usehttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01330-1
mdprc 002 11 17 000Stryker 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 000Hospira 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 000BioArray Solutions LtdMIA FORA NGShttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01303-1
mdprc 104 10 17 000Fresenius Dialysis Treatment Therapy Pack 105http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01341-1
mdprc 099 10 17 000Zevex 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 000Stryker Thoracic Pedicle Feeler http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01337-1
mdprc 097 10 17 000Hospira IncHospira 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 000Sunrise MedicalOxford Dipper Hoist http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01233-1
mdprc 079 10 17 000Liko ABLiko 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 000Biomet 3i Inc.Abut Gold Friction-Fithttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00896-1
mdprc 072 10 17 000Cepheid Xpert EV Assayhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01257-1
mdprc 071 10 17 000ICU Medical, Inc. Various Safeset and Transpac Blood Pressure Transducer Setshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01237-1
mdprc 070 10 17 000Medtronic O-arm O2 Surgical Imaging Systemhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01243-1
mdprc 048 10 17 000MEDIPLAST ABVarious Disposable Catheter Mountshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01268-1
mdprc 047 10 17 000Sysmex America IncFluorocell PLT reagenthttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01275-1
mdprc 028 10 17 000Bard Pcripheral Vascular (BPV)Max-Core Disposable Core Biopsy Instrumentshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01238-1
mdprc 027 10 17 000Boston ScientificAuriga XL 4007 Laser System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01215-2
mdprc 026 10 17 000Boston ScientificAuriga XL 4007 Laser Systemhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01213-1
mdprc 025 10 17 000Hill-RomProgressa Bed System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01216-1
mdprc 024 10 17 000Intelerad Medical Systems Inc.IntelePACS InteleViewerhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01234-1
mdprc 023 10 17 000SIEMENSSOMATOM go.Up and SOMATOM go. Nowhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01261-1
mdprc 022 10 17 000SIEMENSMultiple Artis systems http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01240-1
mdprc 060 09 17 000iMDsoft LtdMetaVision ICU http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01173-2
mdprc 059 09 17 000ThermoFisher Scientific Microbiology PerthOxoid AST Disc - Ceftazidime CAZ10 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01190-1
mdprc 058 09 17 000St. Jude Medical IncNM 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 000Siemens Medical SolutionsArtis 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 000Radiometer America IncRadiometer AQT90FLEX Immunoassay analyser http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01195-1
mdprc 055 09 17 000OculentisLentis Foldable Intraocular Lenses (IOL) http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01194-1
mdprc 054 09 17 000Mediplas Respiratory Products Sdn BhdVarious Disposable Catheter Mounts http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01168-1
mdprc 053 09 17 000Immucor 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 000Gainsky Pty LtdFreedom Healthcare Quad Walkers http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01130-1
mdprc 051 09 17 000Bio-Rad Medical Diagnostics GmbHDiaMed Q.C. System.http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01183-1
mdprc 033 09 17 000Philips HealthcareIntelliVue Patient Monitors Performing 12-Lead ECG Monitoringhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01171-1
mdprc 032 09 17 000Thermo Fisher Scientific.TM0268 GC Sugar Sethttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01157-1
mdprc 031 09 17 000Smiths MedicalGraseby 3300 Pump and Graseby 3000 Series Accessorieshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01146-1
mdprc 030 09 17 000Pride Mobility Products LtdIris Hi Lo Bedhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00842-1
mdprc 103 08 17 001Thermo Fisher Scientific Inc.Streptex Rapid Latex Agglutination Test.Swissmedic
mdprc 013 09 17 000Bayer 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 000Stryker Howmedica Osteonics CorpMako THA Application User Guideshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01129-1
mdprc 061 08 17 001Smith & Nephew incPolarstem Cardan for 21000438 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157987
mdprc 011 09 17 000Siemens Medical SolutionsArtis one system with DP Transceiver below version 03http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01127-1
mdprc 010 09 17 000Seqirus Pty LtdEpiclone 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 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostic Products Signal Reagenthttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01090-1
mdprc 008 09 17 000Hologic IncAffirm 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 000Thermo Fisher Scientific Inc.Remel Wellcolex Colour Shigella Reagenthttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01103-1
mdprc 101 08 17 000Siemens Healthcare DiagnosticsSysmex CS-5100 Analyserhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01098-1
mdprc 099 08 17 000Applied Medical ResourcesKii Abdominal Troacarhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01102-1
mdprc 063 08 17 000Vygon UK LtdXRO Umbilical Cathetershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01019-1
mdprc 062 08 17 000The Binding SiteHuman 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 000Smith & 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 000Safapac LtdS7XTRA Concentrate 5 Litre bottles http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00918-1
mdprc 058 08 17 000PENTAX 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 000Ortho-Clinical DiagnosticsVITROS Performance Verifier II http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01008-1
mdprc 055 08 17 000Mediplas Respiratory Products Sdn BhdDisposable 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 000Beckman CoulterGentian Cystatin C Calibrator Kit. http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00992-1
mdprc 053 08 17 000AbbottAbbott RealTime HIV-1 Assay http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01057-1
mdprc 052 08 17 000FUJIFILM Medical SystemsAMULET Digital Mammography Systemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00961-1
mdprc 009 08 17 000Stanmore Implants JTS System Grower Drive Unitshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00865-1
mdprc 008 08 17 000OlympusHF-Resection Electrodes http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00863-1
mdprc 007 08 17 000Maquet Heater Unit HU 35 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00917-1
mdprc 006 08 17 000GE HealthcareCareScape 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 000FUJIFILM Medical SystemsFujifilm Digital Mammography System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00903-1
mdprc 004 08 17 000C 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 000bioMerieux 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 000Bayer 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 000Beckman CoulterSynchron Systems Salicylate Reagenthttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00844-1
mdprc 080 07 17 000Alere LTDAlere HIV Combohttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00856-1
mdprc 079 07 17 000Baxter Corp CanadaHomeChoice and HomeChoice PRO Automated PD Cyclershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00855-1
mdprc 078 07 17 000Cosman MedicalNitinol RF Reusable Electrodeshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00846-1
mdprc 077 07 17 000MAKO Surgical CorpMako Internal cPCI Card Cagehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00857-1
mdprc 076 07 17 000Siemens Healthcare Diagnostics GmbHDimension Clinical Chemistry System and Dimension Vista Systemhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00839-1
mdprc 075 07 17 000NOVO NORDISK A/SNovoPen Echohttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00832-1
mdprc 074 07 17 000R82Heron Toilet and Bath Chairshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00858-1
mdprc 072 07 17 000Tornier IncAequalis Ascend Flex Shoulder System PTC Humeral Stemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00860-1
mdprc 068 06 17 001Siemens Healthcare Diagnostics GmbHCalibrator 30 (2 pack) used with ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, Centaur XP and Centaur XPT systemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00747-1
mdprc 031 07 17 000Sysmex CorporationSysmex 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 000Roche 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 000OlympusSealing 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 000Nortec NZPivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip fasteninghttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00522-1
mdprc 027 07 17 000MAQUET Cardiovascular LLCMaquet/Datascope CS Intra-Aortic Balloon Pumpshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00834-1
mdprc 026 07 17 000Intersurgical LimitedBVM Manual Manual Resuscitation Systemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00838-1
mdprc 025 07 17 000ICU Medical, Inc.Plum 360 Infusion Systemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00729-1
mdprc 024 07 17 000CODAN 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 000bioMerieux IncBK 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 000bioMerieux 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 000BioMerieux 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 000Beckman 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 000Beckman CoulterCOULTER LH and HmX Analyzershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00820-1
mdprc 018 07 17 000Beckman CoulterRecapper 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 001St. 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 000Beckman Coulter Valproic Acid and Antibiotic TDM Multi-Calibratorhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00749-1
mdprc 069 06 17 000MEDTECH SARosa One 3.1http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2016-RN-01658-1
mdprc 066 06 17 000Thermo 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 001Radiometer America IncABL90Flex 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 000Philips HealthcarePhilips 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 000Seqirus Pty LtdPhenocell B 0.8% and 3% and Abtectcell III 0.8%RhDhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00658-1
mdprc 061 06 17 000Shimadzu Medical SystemsShimadzu Ceiling Type X-ray Tube Supporthttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00698-1
mdprc 060 06 17 000TransMedicsOrgan Care System (OCS) Heart systemhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00724-1
mdprc 021 06 17 001Cook MedicalVueOptic Visualisation Source & Flexor Vue Deflecting Endoscopic Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155462
mdprc 030 06 17 000Alcon LenSx, IncAlcon 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 000Beckman CoulterPrepPlus & PrepPlus 2http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00717-1
mdprc 028 06 17 000Cook Endoscopy.OptiLite Multi-Use Holmium Laser Fibershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00694-1
mdprc 022 06 17 000Terumo BCT IncVarious Terumo Introducer Kits http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00713-1
mdprc 020 06 17 000Beckman CoulterDxH 500 Haematology Analyserhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00705-1
mdprc 019 06 17 000Tobrix BV.Laser Guide, Endotherapy http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00707-1
mdprc 011 06 17 000Siemens 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 001Zimmer inc.Trauma Implants - intramedullary nailsNCMDR
mdprc 153 05 17 000Thermo Fisher Scientific Inc.Dynabeads Reagentshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00645-1
mdprc 152 05 17 000Siemens 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 000GE HealthcareOEC Elite systems http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00643-1
mdprc 150 05 17 000Applied Medical ResourcesKii abdominal trocars http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00636-1
mdprc 149 05 17 000Alba BioscienceALBAclone 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 001Balt ExtrusionMicrocatheter SONIC 1.5FSwissmedic
mdprc 031 05 17 001SIEMENSSensis system https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154828
mdprc 123 05 17 000Life Technologies CorporationLABType DNA Typing Testshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2016-RN-01380-1
mdprc 095 05 17 001Medtronic SAPolysorb Braided Absorbable Suture and EndoStitch Loading Unit with Polysorb Suturehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00589-1
mdprc 114 05 17 000Diagnostica StagoAsserachrom 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 000AbbottARCHITECT Free T4 Reagent.http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00562-1
mdprc 099 05 17 000Beckman Coulter Inc. Synchron Systems Microalbumin (MA) Reagenthttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00627-1
mdprc 098 05 17 000Cook Inc,Pereyra Ligature Carriers, Pereyra-Raz Ligature Carriers, and Stamey Needleshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00539-1
mdprc 097 05 17 000Cook MedicalEndoscopic Curved Needle Driver, LapSac Introducer and LapSac Introducer Sethttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00584-1
mdprc 096 05 17 000MedlineJackson-Pratt Perforated and Hemaduct Wound Drainage Systemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00565-1
mdprc 094 05 17 000Nihon Kohden Corp.Corpuls3 CO2 Disposable Naso-oral Adaptor Caponehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00535-1
mdprc 093 05 17 000Sysmex America Inc. XN-550 Hematology IVD Analyzershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00485-1
mdprc 092 05 17 000Yafho Bio - Technology CO. LtdUltrasound 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 001Abbott Medical Optics Inc.Healon Ophthalmic Viscoelastic Deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154835
mdprc 051 05 17 000Teleflex MedicalWECK Visistat 35R Skin Staplershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00508-1
mdprc 050 05 17 000Stryker CommunicationsVisum LED Surgical Lighting system http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00455-1
mdprc 049 05 17 000SIEMENSSOMATOM 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 000Parker HealthcareTB2000 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 000OlympusMonopolar HF Resection Electrodes http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00498-1
mdprc 045 05 17 000Cook 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 000Caesarea Medical Electronics LtdBodyGuard Pump IV Administration Set http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00446-1
mdprc 043 05 17 000Bausch & 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 000Vascular 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 000Stryker 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 000Siemens Healthcare Diagnostics GmbHADVIA Centaur Systems Insulin Calibrators and ReadyPack Kitshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00488-1
mdprc 022 05 17 000Quantel MedicalLaser photocoagulator Easyret http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00507-1
mdprc 021 05 17 000Natus 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 000bioMerieux 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 001Covidien LLCValleylab Laparoscopic Handset, Four-Function http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00165-1
mdprc 062 03 17 000William Cook Cook Bush SL and Bush DL Ureteral Illuminating Cathetershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00365-1
mdprc 061 03 17 000SIEMENSWireless 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 000Kerr CorporationSealapex Xpress http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00314-1
mdprc 059 03 17 000DiaSorin Inc. Liaison C-Peptid Assay http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00323-1
mdprc 053 03 17 000Philips HealthcareBrightView, 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 000Philips HealthcarePhilips Ingenuity CT system http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00261-1
mdprc 044 03 17 000Philips HealthcarePhilips 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 000Ortho-Clinical DiagnosticsVITROS Chemistry Products VANC Reagenthttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00302-1
mdprc 042 03 17 000Getinge Disinfection ABGetinge HS33 Sterilsershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00251-1
mdprc 041 03 17 000Genesis Biotech Pty LtdPregSure Digital Pregnancy Test & Pregsure Pregnancy Testhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00230-1
mdprc 040 03 17 000Ellex Medical Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00213-1
mdprc 039 03 17 000DePuy International LtdScrewdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Couplinghttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00304-1
mdprc 038 03 17 000ConMed CorporationConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece Sheathshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00293-1
mdprc 037 03 17 000Aero HealthcareAerowound Combine Dressing ACD2040S, size 20cm x 40cmhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00283-1
mdprc 083 01 17 002Siemens Healthcare DiagnosticsCalibrator A used with ADVIA Centaur FT4 (free thyroxine) assay on the ADVIA Centaur, Centaur XP, Centaur XPT Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152666
mdprc 044 02 17 000Siemens 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 000Siemens Healthcare Diagnostics GmbHADVIA Centaur XPT System http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00208-1
mdprc 042 02 17 000Diagnostic Solutions Pty LtdABC1 HLA Typing Tray included in ABC1 / ABC2 Kitshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00169-1
mdprc 041 02 17 000BrainLABBrainlab 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 000Boston Scientific.AngioJet Ultra 5000A Console - http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00183-1
mdprc 039 02 17 000AbbottStarClose SE Vascular Closure System (VCS) http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00211-1
mdprc 038 02 17 000Roche Diagnostics LtdLysercell 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 000Physio Control Inc. LIFEPAK 1000 Automatic External Defibrillatorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00114-1
mdprc 036 02 17 000IRIS DiagnosticsiChemVELOCITY Automated Urine Chemistry Systems http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00170-1
mdprc 013 06 16 001Roche Diagnostics CorpONLINE 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 000Saraya Australia Pty LtdAcecide Test Strips http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00139-1
mdprc 128 01 17 001Siemens Healthcare DiagnosticsInnovance 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 000Roche Diagnostics LtdSysmex XN-9000 http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00089-1
mdprc 133 01 17 000RaySearch 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 000Radiometer MedicalRadiometer ABL800 Series Analysershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00137-1
mdprc 131 01 17 000Radiometer Inc. Radiometer ABL90 Series Analysershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00121-1
mdprc 130 01 17 000Carestream HealthDRX Revolution Mobile X-Ray System http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00085-1
mdprc 129 01 17 000Abacus ALS Pty LtdIRT Screening Assayhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00087-1
mdprc 127 01 17 000Physio Control IncPhysio Control Inc http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00102-1
mdprc 126 01 17 000CepheidXpert BCR-ABL Monitor assay http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00083-1
mdprc 069 09 14 001The Binding SiteHuman IgG4 Kit Immage Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152025
mdprc 084 01 17 000SIEMENSMammomat Inspiration System http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00071-1
mdprc 082 01 17 000ISOMedArterial 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 000Biomet Inc.Comprehensive Reverse Shoulder Trayshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00021-1
mdprc 080 01 17 000Biomet Inc. Vanguard Open Box Femoral Componentshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00055-1
mdprc 079 01 17 000Abacus ALS Pty LtdCryptococcal 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 001Ortho-Clinical DiagnosticsVITROS 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 000Philips HealthcareTranspac 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 000Siemens 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 000Diagnostic Solutions Pty LtdPak Lx Assay http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00056-1
mdprc 022 01 17 000Siemens 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 000Hospira IncPlum 360 Infusion Pump http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00001-1
mdprc 012 01 17 000Nucletron bvOncentra 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 000SCIENT’XArsenal Set-Screwhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01639-1
mdprc 007 01 17 000Bard 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 000CareFusion..SmartSite Add-On Bag Access Deviceshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01631-1
mdprc 005 01 17 000ConMed CorporationConmed GS2000 - 50L Abdominal Insufflator http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01601-1
mdprc 004 01 17 000Hill Rom IncMedical Mattresses and Mattress Covershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01613-1
mdprc 003 01 17 000Ortho-Clinical DiagnosticsVITROS Chemistry Products UPRO Slides .http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01627-1
mdprc 002 01 17 000Shantex Pty LtdVinyl examination/treatment glove, non-powdered http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01596-1
mdprc 001 01 17 000SIEMENSDimension Vista V-LYTE Integrated Multisensorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01652-1
mdprc 126 12 16 000Ortho-Clinical DiagnosticsReagent 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 000Hirtz & 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 000Philips HealthcarePhilips 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 000Philips Ingenia 1 .5T and Ingenia 3.OT MR systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01595-1
mdprc 109 12 16 000iNova Pharmaceuticals Australia Pty LtdAlgerbrush II and Algerbrush II Accessories http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01586-1
mdprc 108 12 16 000CareFusionAlaris System PC Unitshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01565-1
mdprc 107 12 16 000Bio-Rad ID-DC Screening II http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01574-1
mdprc 106 12 16 000Beckman Coulter IncUniCel DxC Synchron Wash Concentrate II http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01619-1
mdprc 120 11 16 001Bayer Healthcare LLC..Source Administration Sets Used with Medrad Intego PET Infusion Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01498-1
mdprc 005 12 16 001Laerdal Medical AsLaerdal Compact Suction Unit 4 (LCSU 4)NCMDR
mdprc 056 12 16 000Parker HealthcareTB2000 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 000AbbottArchitect Active-B12 Reagent Kit http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01579-1
mdprc 054 12 16 000MAQUET IncAtrium Chest Drains http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01580-1
mdprc 049 12 16 000Radiometer MedicalRadiometer ABL700 and ABL800 series blood gas analysershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01538-1
mdprc 035 12 16 000Oventus Pty LtdO2Vent T.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01554-1
mdprc 033 12 16 000Siemens Healthcare DiagnosticsCentraLink Data Management Systems http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01576-1
mdprc 032 12 16 000CareFusion 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 000Oventus Pty LtdO2vent Thttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01572-1
mdprc 009 12 16 000Siemens Healthcare Diagnostics ProductImmulite 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 000Roche Diagnostics CorpHomocysteine 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 000Uniwide Australia Import Export Pty LtdDeluxe First Aid Kit http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01515-1
mdprc 020 10 15 002Ortho-Clinical DiagnosticsVITROS Chemistry Products Calibrator Kit 9 http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01547-1
mdprc 006 12 16 000Teleflex MedicalWECK Visistat 35W Skin Stapler http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01545-1
mdprc 160 11 16 000Taylor Bio-Medical Pty LtdQuantum 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 000Philips BurtonPhilips 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 000Spacelabs Healthcare IncSpacelabs Healthcare Xhibit Central Station Model 96102http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00572-1
mdprc 137 11 16 000Life HealthcareKasios TCP and Kages http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01443-1
mdprc 119 10 16 001Roche Diagnostics CorpTina-quant Haemoglobin A1c Gen.2 used with COBAS INTEGRA 400 plus analyserhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150150
mdprc 126 11 16 000Stryker InstrumentsK-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 000Surgical Specialties / AngiotechADVANCE HA Coated TitaniumTibial Bases http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00883-1
mdprc 124 11 16 000Supergloves Australia Pty LtdSupergloves Vinyl Examination Gloves http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01481-1
mdprc 123 11 16 000Radiometer America IncPico 70 Arterial blood sampler. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01500-1
mdprc 122 11 16 000Maquet Cardiopulmonary AGMAQUET HLS and PLS Sets http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01514-1
mdprc 121 11 16 000Life HealthcareNeuro Flap Fix Kit http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01497-1
mdprc 119 11 16 000Stryker OrthopaedicsOffset Cup Reamer Handleshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01468-1
mdprc 118 11 16 000Siemens Medical SolutionsSOMATOM Force. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01461-1
mdprc 117 11 16 000In Vitro TechnologiesFreelite 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 000Australian Comfort GroupPressure 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 000Beckman Coulter IncAU680 chemistry analysers http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01426-1
mdprc 068 11 16 000Draeger Medical Systems IncInfinity Acute Care Monitoring System http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01412-1
mdprc 067 11 16 000Elekta 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 000Endologix IncNellix EndoVascular Aneurysm Sealing System. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01390-1
mdprc 065 11 16 000Maquet Cardiopulmonary AGAtrium 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 000Medtronic..ARRIVE Braided Transseptal Sheath http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01432-1
mdprc 063 11 16 000Ortho-Clinical DiagnosticsVITROS 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 000Allegra Orthopaedics LimitedActive Knee Total Knee Replacement System http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01395-1
mdprc 148 10 16 000Siemens Healthcare Diagnostics GmbHChemistry 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 000HoneywellHoneywell http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01226-1
mdprc 144 10 16 000Emergo AustraliaRaySearch RayStation 5. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01364-1
mdprc 143 10 16 000Bard Australia Pty LtdBard Inlay Optima Ureteral Stents http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01369-1
mdprc 120 10 16 000Siemens Healthcare Diagnostics GmbHAptio Automation Modules http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01310-1
mdprc 118 10 16 000Philips HealthcareIntelliVue MX40 Patient Monitors used with IntelliVue Information Centers iXhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01297-1
mdprc 117 10 16 000Invacare 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 000In Vitro TechnologiesFreelite Human Kappa Free Kit http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01298-1
mdprc 115 10 16 000Haemokinesis Pty LtdALBAclone Advanced Partial RhD Typing Kit http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01323-1
mdprc 114 10 16 000CepheidXpert HIV-1 Viral Load Assayshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01272-1
mdprc 113 10 16 000Vision RTAlignRT 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 000Pro-Pac Packaging Aust Pty LtdFeather Touch Vinyl Examination Gloves http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01292-1
mdprc 111 10 16 000Bard Access SystemsSenoMark UltraCor MRI 14 Gauge Breast Tissue Markershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01314-1
mdprc 058 10 16 000Siemens Healthcare Diagnostics GmbHAutomatic QC Cartridge tHb Level 1http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01237-1
mdprc 036 10 16 000Philips HealthcareVarious 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 000Hospira IncPlum 360 Infusion Pump. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01199-1
mdprc 034 10 16 000Bosco Medical AustraliaPennine Healthcare Ryles Tubes http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01156-1
mdprc 033 10 16 000Arthrex IncArthrex ITD Articulating Arm 300 + 350MM http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01192-1
mdprc 031 10 16 000ZOLL Medical CorpAVOXimeter 1000E Cuvetteshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01265-1
mdprc 030 10 16 000TIDI Products LLCZero-Gravity Radiation Protection Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01289-1
mdprc 029 10 16 000Siemens Healthcare Diagnostics GmbHChemistry 1 Calibratorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01243-1
mdprc 028 10 16 000Radiometer America IncRadiometer TCM5 Flex Monitorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01264-1
mdprc 027 10 16 000Ortho-Clinical DiagnosticsVITROS Automation Solutions configured with a Thermo Scientific Centrifuge Modulehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01254-1
mdprc 026 10 16 000Elekta Monaco V5.10 and V5.20http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01281-1
mdprc 025 10 16 000CynosureSterile 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 000B Braun Surgical SASpinocath G22 / G27http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01228-1
mdprc 023 10 16 000Stryker OrthopaedicsLFIT V40 Femoral Heads.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01191-1
mdprc 022 10 16 000Rehab Assist Pty LtdC-series carry bars http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01200-1
mdprc 021 10 16 000Radiometer America IncRadiometer 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 000Philips HealthcarePhilips 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 000Getinge Disinfection ABED-FLOW and ED-FLOW SD Automated Endoscope Reprocessing Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01216-1
mdprc 018 10 16 000Debriflo Pty LtdDebriflo Ultrasonic Wound Irrigation Hand-piece http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01165-1
mdprc 017 10 16 000Beckman CoulterAQUIOS CL Flow Cytometer System http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01209-1
mdprc 016 10 16 000Aero HealthcareNIO-A device http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01138-1
mdprc 015 10 16 000Siemens Medical SolutionsIron 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 000Siemens Healthcare DiagnosticsRAPIDPoint 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 000Roche Diagnostics CorpAccu-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 000PANTHERA ABModel S3 Wheelchairshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01154-1
mdprc 011 10 16 000Diagnostic Solutions Pty LtdFIDS dsDNA Kit http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01184-1
mdprc 010 10 16 000Abacus ALS Pty LtdCoxiella burnetii IFA IgG Kit http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01149-1
mdprc 032 09 16 001AMO Germany GmbHTECNIS 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 000Integra LifeSciences CorporationVentricular Catheter Accessory Kit http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01139-1
mdprc 035 09 16 000Hamilton Medical IncHamilton Medical MR1 Ventilator http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01133-1
mdprc 034 09 16 000CareFusion 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 000bioMerieux IncSensitest Agar http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01142-1
mdprc 140 08 16 000Siemens Healthcare Diagnostics IncDimension & 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 000ThermoFisher Scientific Microbiology PerthOxoid 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 000Medela AGMedela 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 000ConMed CorporationConcept Heatwave Electrode http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01129-1
mdprc 136 08 16 000Stryker CommunicationsStryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mmhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01114-1
mdprc 135 08 16 000Siemens Medical Solutionssyngo 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 000Siemens Healthcare DiagnosticsRAPIDLab and RAPIDPoint BloodGas Analyzershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01098-1
mdprc 133 08 16 000Bard 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 000Siemens Healthcare Diagnostics ProductSysmex 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 001ConMed CorporationConMed ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146783
mdprc 119 08 16 000Siemens Medical SolutionsPrimus, ONCOR and ARTISTE http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01086-1
mdprc 118 08 16 000Amplitude GmbHCemented 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 001LeMaitre Vascular GmbH1.5 mm HYDRO LeMaitre Valvulotome, 40 cmTGA
mdprc 081 08 16 000Hill Rom IncCeiling Bracket, Arch 71 White http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01014-1
mdprc 080 08 16 000Siemens Healthcare Diagnostics GmbHADVIA Centaur Systems Calibrator U (Myoglobin) http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01056-1
mdprc 079 08 16 000Lima OrthopaedicsAllen Wrench 5mm in SMR supplied in instrument sethttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01053-1
mdprc 078 08 16 000Imaxeon Pty LtdCertegra 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 000Emergo Asia Pacific Pty Ltd T/a Emergo AustraliaIntelePACS InteleViewer.. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01045-1
mdprc 076 08 16 000Bard 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 000Abacus ALS Pty LtdCell Marque Rabbit Monoclonal Antibody. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01012-1
mdprc 052 08 16 000AlereINRatio and INRatio 2 PT/INR Monitor Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00999-1
mdprc 051 08 16 000Beckman CoulterUniCel 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 000bioMerieux IncBK 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 000Siemens Healthcare Diagnostics GmbHProstate-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 001Covidien LLCPuritan Bennett 980 Series Ventilator System PB980http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00089-1
mdprc 013 08 16 000SIEMENSAXIOM 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 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostic Products Estradiol Reagent Pack http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00982-1
mdprc 056 12 15 001Abbott Vascular Devices Div Abbott Laboratories IncAbsorb Bioresorbable Vascular Scaffold (BVS) System http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01188-1
mdprc 174 07 16 000Abacus ALS Pty LtdImmunoCAP Specific IgE Control H http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00978-1
mdprc 173 07 16 000DePuySynthesLocking 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 000In Vitro TechnologiesSteelco Washer Disinfectors http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00909-1
mdprc 171 07 16 000MAQUET IncMaquet 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 000Medline Industries IncMedline 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 000Siemens Healthcare Diagnostics GmbHADVIA 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 000Smith & NephewTrigen 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 000Siemens Healthcare Diagnostics GmbHSOMATOM 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 000Philips HealthcareMultiDiagnost 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 000LivaNova PLCSynthesis, 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 000DiaSorin IncLIAISON Estradiol II Gen Assay http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00942-1
mdprc 133 07 16 000ConvaTecFrazier Suction instrument http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00923-1
mdprc 100 07 16 000Sunrise MedicalQuickie Q7 Manual Wheelchair http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00892-1
mdprc 099 07 16 000Stryker OrthopaedicsTriathlon Modular Handleshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00910-1
mdprc 098 07 16 000Siemens Medical SolutionsArtis systems with 19" Live Display http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00924-1
mdprc 097 07 16 000Rex Bionics Australia PtyREX Rehab and REX P Devices http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00852-1
mdprc 096 07 16 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostic Products HBsAg Controls http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00874-1
mdprc 095 07 16 000Merge 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 000Merge 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 000Medline International Two Australia Pty LtdGeneral 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 000Covidien LLCCovidien Valleylab Laparoscopic Wire Retractable Electrode http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00922-1
mdprc 091 07 16 000Beckman 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 000Baxter HealthcareVASCU-GUARD Peripheral Vascular Patcheshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00879-1
mdprc 089 07 16 000B Braun Surgical SASafil Quick http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00855-1
mdprc 052 07 16 000Zimmer incTorque 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 000Roche Diagnostics Ltdcobas 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 000Merge Healthcare Corp.iConnect Enterprise Archiveshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00873-1
mdprc 049 07 16 000Merge Healthcare Corp.Cardio Information Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00871-1
mdprc 048 07 16 000Merge 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 000Merge Healthcare Corp.CADstream MRI Systems Used with GE Phased Array Uniformity Enhancementhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00868-1
mdprc 046 07 16 000Merge Healthcare Corp.iConnect Enterprise Archives with Tier 2 Storagehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00864-1
mdprc 045 07 16 000Iona Medical ProductsIona Medical ProductsVolker LTC bed http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00835-1
mdprc 044 07 16 000Emergo Asia Pacific Pty Ltd T/a Emergo AustraliaMerge iConnect Enterprise Archive (iCEA) http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00860-1
mdprc 043 07 16 000Emergo Asia Pacific Pty Ltd T/a Emergo AustraliaMerge 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 000Emergo Asia Pacific Pty Ltd T/a Emergo AustraliaMerge PACS http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00861-1
mdprc 041 07 16 000Emergo Asia Pacific Pty Ltd T/a Emergo AustraliaMerge OrthoCase http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00869-1
mdprc 040 07 16 000Emergo Asia Pacific Pty Ltd T/a Emergo AustraliaMerge PACS http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00863-1
mdprc 125 06 16 000Stryker Howmedica Osteonics CorpTrident Constrained Liner Impactor Tipshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00808-1
mdprc 124 06 16 000Sirona 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 001Siemens Healthcare Diagnostics IncDimension Vista Creatinine (CRE2) Flex reagent cartridgehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00807-1
mdprc 122 06 16 000Siemens Healthcare Diagnostics GmbHADVIA 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 000QIAGEN LtdQIAsymphony DSP DNA Mini Kits http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00814-1
mdprc 120 06 16 000MAQUET IncSERVO-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 000Integra NeuroSciencesACHILLON 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 000Imaxeon Pty LtdMedrad MRXperion MR Injection System http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00828-1
mdprc 117 06 16 000Elekta 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 000Draeger Medical Systems IncDräger Babytherm Infant Warmer http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00794-1
mdprc 115 06 16 000DePuySynthesProdisc-C Vivo Cervical Disc Implant http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00849-1
mdprc 113 06 16 000Boston ScientificXenform 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 000Baxter Corp CanadaSoftpac C299 http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00815-1
mdprc 097 06 16 000Amplitude GmbHScore 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 000Merck Serono LimitedMaxter Catheters Entral pH Indicator Strips http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00768-1
mdprc 011 06 16 001Draeger Medical Systems IncDrager Ventstar Paediatric Circuit MHRA
mdprc 061 03 16 001Siemens Healthcare Diagnostics IncBlood Urea Nitrogen (BUN) Flex Reagent Cartridgehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00211-1
mdprc 052 06 16 000RaySearch Laboratories ABRaySearch RayStation 5TGA
mdprc 051 06 16 000Medtronic IncActiva 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 000Hill Rom IncCompella Bariatric Bed System, Controllers and Air Surfaceshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00745-1
mdprc 049 06 16 000GE HealthcareDiscovery MR750w . http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00773-1
mdprc 048 06 16 000Carl Zeiss Meditec IncLumaDent Light Battery Charger http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00746-1
mdprc 047 06 16 000Bosco Medical AustraliaSorbsan 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 000StrykerTarget Nano Detachable Coil http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00772-1
mdprc 045 06 16 000Teleflex MedicalNeonate Resuscitator with Coded Airway & Filter Resuscitator Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00736-1
mdprc 012 06 16 000Philips 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 000Zimmer incSterile-Packaged Knee Implants http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00660-1
mdprc 145 05 16 000Stryker InstrumentsSpecialty 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 000Siemens Healthcare Diagnostics GmbHHettich Centrifuge Bucket Model 4464-R http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00663-1
mdprc 143 05 16 001Siemens Healthcare Diagnostics GmbHDimension 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 000Ortho-Clinical DiagnosticsVITROS 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 000GE HealthcareMSK 1.5T Extreme and Optima MR430shttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00652-1
mdprc 140 05 16 000Elekta CMS SoftwareHexapod 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 000Volcano CorpVolcano S5, S5i, CORE, CORE Mobile Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00602-1
mdprc 100 05 16 000ZOLL Medical CorpAVOXimeter Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00618-1
mdprc 099 05 16 000Thermo FisherRAPID Hp StAR Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00620-1
mdprc 098 05 16 000Siemens Healthcare Diagnostics GmbHTnI-Ultra (Troponin) Assay, 100 and 500 testshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00603-1
mdprc 097 05 16 000Schell MedicalResus-EZY Manual Resuscitatorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00645-1
mdprc 096 05 16 000Philips HealthcareBrilliance 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 000Philips BurtonIngenuity Core128 CT Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00597-1
mdprc 094 05 16 000HeartWare IncHeartWare HVAD systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00580-1
mdprc 093 05 16 000Diagnostic Solutions Pty LtdLIFECODES HLA-C eRES SSO Typing Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00591-1
mdprc 092 05 16 000Cordis CorporationPRECISE RX and PRECISE PRO RX Nitinol Stent Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00625-1
mdprc 091 05 16 000Alcon Laboratories Inc.CENTURION Vision System Fluidics Management Packshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00613-1
mdprc 003 05 16 001Bard Pcripheral Vascular (BPV)EnCor ProbesMHRA
mdprc 055 05 16 000Smith & NephewBirmingham Hip Product Range http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00436-1
mdprc 054 05 16 000Siemens Healthcare Diagnostics GmbHADVIA Centaur XPT Systems http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00573-1
mdprc 053 05 16 000Siemens Healthcare Diagnostics GmbHADVIA Chemistry XPT System with software versions 1.0.3 and 1.1http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00569-1
mdprc 052 05 16 000Leica Microsystems, Inc.Novocastra Liquid Mouse Monoclonal Antibody Calretininhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00563-1
mdprc 051 05 16 000Huntleigh HealthcareMaxi Air Blower Unit - Model 230V http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00560-1
mdprc 013 05 16 000Emergo Asia Pacific Pty Ltd T/a Emergo AustraliaG-scan Brio Magnetic Resonance Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00499-1
mdprc 012 05 16 000GE HealthcareGE 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 000Carestream Health Inc Div Onex CorpImage Suite http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00501-1
mdprc 010 05 16 000Australasian Medical & Scientific LtdEssure Permanent Birth Control http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00243-1
mdprc 009 05 16 000Alcon 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 000AGFA 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 000Trumpf Medical Systems, Inc.iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lightinghttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00458-1
mdprc 006 05 16 000Stryker CommunicationsCinchLock SS Knotless Anchor with Inserter http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00484-1
mdprc 005 05 16 000MAQUET Cardiovascular LLCCardiosave 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 000Cook Inc,Beacon Tip Catheters http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00483-1
mdprc 056 04 16 001Stryker CommunicationsPneumoSure XL High Flow Insufflatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144721
mdprc 115 04 16 000Siemens Medical SolutionsInsulin-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 000Medtronic LimitedGiven Imaging Bravo pH monitoring systems http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00477-1
mdprc 113 04 16 000Covidien LLCCapnostream 20p Patient Monitors - battery pack http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00485-1
mdprc 112 04 16 000Allegra Orthopaedics LimitedPF6 Tube Assembly http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00493-1
mdprc 102 04 16 000Philips BurtonIngenuity Core http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00476-1
mdprc 101 04 16 000Leica 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 000Boston Scientific Cardiac Rhythm Management GroupLotus Valve System. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00447-1
mdprc 088 04 16 000Siemens Medical Solutionse.cam and all Symbia systems with foresight detectorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00419-1
mdprc 087 04 16 000Ortho-Clinical DiagnosticsVITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00420-1
mdprc 086 04 16 000Mizuho OSIMizuho General Purpose Operating Tablehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00394-1
mdprc 085 04 16 000Life HealthcareASC Neuro Spongeshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00433-1
mdprc 084 04 16 000Beckman CoulterIRISpec CA/CB/CC Control Kit and IRISpec CA/CB Control Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00437-1
mdprc 083 04 16 000Aero HealthcareMilitary Trauma & Haemorrhage Wound Dressinghttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00370-1
mdprc 072 04 16 000Siemens Healthcare DiagnosticsEZee-Nest Insert Cups used with ADVIA Centaur CPhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00389-1
mdprc 071 04 16 000PerkinElmer Life and Analytical SciencesLifeCycle for Prenatal Screening…http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00413-1
mdprc 070 04 16 000Navilyst MedicalPICC Catheters Contained in Various Valve Technology Kitshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00383-1
mdprc 069 04 16 000Lovell Surgical Supplies International Pty LtdHypothermia and Hyperthermia deviceshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00362-1
mdprc 068 04 16 000Hoya CorporationPentax ED-3490TK Video Duodenoscopehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00238-1
mdprc 067 04 16 000Bio-Rad Laboratories IncID 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 000Intelerad Medical Systems Inc..INTELEPACShttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00346-1
mdprc 016 04 16 000Siemens Medical SolutionsAcuson 2000 ultrasound systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00360-1
mdprc 015 04 16 000Siemens Medical SolutionsDimension 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 000Thermo Fisher Scientific OyOxoid Nitrocefin (+ Reconstitution Fluid)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00323-1
mdprc 190 03 16 000Siemens Medical SolutionsAcuson SC200 ultrasound systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00353-1
mdprc 189 03 16 000Siemens Healthcare DiagnosticsVersant kPCR Molecular System Sample Preparationhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00327-1
mdprc 188 03 16 000Siemens Healthcare Diagnostics GmbHMethotrexate Assay performed on Syva Emit Methotrexate Application (DVMTX.1) for the Dimension Vista Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00332-1
mdprc 187 03 16 000Siemens Healthcare Diagnostics GmbHDimension and Dimension Vista Clinical Chemistry Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00350-1
mdprc 186 03 16 000Philips HealthcareAllura Xperhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00274-1
mdprc 185 03 16 000Philips HealthcareMobileDiagnost wDR Release1 and 2http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00351-1
mdprc 184 03 16 000Philips HealthcareBrilliance CT and Ingenuity CThttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00340-1
mdprc 183 03 16 000Ortho-Clinical DiagnosticsTCAutomation 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 000Ellex Medical Pty LtdIntegre 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 000Boston Scientific LtdFetch 2 Aspiration Catheter http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00359-1
mdprc 149 03 16 001Smith & NephewTOPAZ MicroDebrider Wandhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00275-1
mdprc 151 03 16 000Stryker NeurovascularNeuroform Atlas Stent Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00298-1
mdprc 150 03 16 000SIEMENSSyngo X-Workplace with software version VD10Ehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00267-1
mdprc 148 03 16 000ClaveGuard Pty LtdDiathermy Pencilhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00280-2
mdprc 101 03 16 000Alcon Laboratories IncVERION Reference Unit (Vision Planner)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00255-1
mdprc 100 03 16 000In Vitro TechnologiesFreelite Human Kappa Integra Kit.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00231-1
mdprc 099 03 16 000Siemens Healthcare Diagnostics GmbHADVIA 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 000ThermoFisher Scientific Microbiology PerthB.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 000Siemens Healthcare Diagnostics GmbHDimension Vista Chemistry 3 Calibrator http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00236-1
mdprc 066 03 16 000Mckesson Medical Imaging GroupHorizon Medical Imaging products.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00226-1
mdprc 065 03 16 000Helena LaboratoriesSafe-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 000GE HealthcareSIGNA Pioneer MR systems http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00242-1
mdprc 063 03 16 000DePuySynthesLocking 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 000Bard Access SystemsARCTICGEL Pads http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00234-1
mdprc 060 03 16 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostic Products Total B-hCG II Reagent Packs & Calibratorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00209-1
mdprc 059 03 16 000Emergo Asia Pacific Pty Ltd T/a Emergo AustraliaIntelePACS InteleViewerhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00199-1
mdprc 058 03 16 000Covidien LLCCovidien Emprint Percutaneous Antenna (short, standard and long) with Thermosphere Technologyhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00210-1
mdprc 057 03 16 000Abacus ALS Pty LtdQuikRead go wrCRP and QuikRead go wrCRP+Hbhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00203-1
mdprc 056 03 16 000CoreMed Pty LtdSpiggle & Theis ENThttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00184-1
mdprc 055 03 16 000Conceiveplease Pty LtdConceiveplease One Step HCG Urine Pregnancy testhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00190-1
mdprc 054 03 16 000Boston ScientificBoston Scientific Urogynaecological Surgical Meshes http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00120-1
mdprc 053 03 16 000Biomet IncVerso Shoulder Forked Retractorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00206-1
mdprc 052 03 16 000B Braun Medical IncSangofix set with hand pumphttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00185-1
mdprc 051 03 16 000Arrow International IncARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion Kitshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00204-1
mdprc 094 01 16 001Resmed LimitedAstral Ventilators - ResMed Astral 100 & Astral 150 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143003
mdprc 021 01 16 001bioMerieux IncAPI ZYM Bhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142938
mdprc 067 02 16 000Biomet IncDVR ePAKhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00142-1
mdprc 066 02 16 000Imaxeon Pty LtdKlikfit CT Syringe with QFT and 75cm Extension tubehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00173-1
mdprc 065 02 16 000DePuySynthesUniversal Battery Charger II (UBC II)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00175-1
mdprc 064 02 16 000Covidien LLCKangaroo Polyurethane Feeding Tubehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00130-1
mdprc 063 02 16 000Actelion Pharmaceuticals Australia Pty LtdVeletri Consumables Kit http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00147-1
mdprc 062 02 16 000Beckman CoulterRotor 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 000bioMerieux IncVIDAS TOXO IgM Assayhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00159-1
mdprc 060 02 16 000CK Surgitech Pty LtdSureclip and Sureclip Plus Haemostasis Clipshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00181-1
mdprc 142 02 14 002Draeger Medical Systems IncOxylog Transport Ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142495
mdprc 022 01 16 001DePuySynthesPFNA NailsTGA
mdprc 032 02 16 000Bio-Rad Laboratories IncAnti-Jk (Jk1).http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00117-1
mdprc 030 02 16 000GE HealthcareCarestation 620 A1, 650 A1, and 650c A1http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00143-1
mdprc 029 02 16 000Integra LifeSciencesPyroTitan Humeral Resurfacing Arthroplasty Shapershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00091-1
mdprc 028 02 16 000Medtronic IncTerumo CVS CDI H/S Cuvette provided within the Medtronic Perfusion Tubing Packhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00124-1
mdprc 027 02 16 000OlympusModel TJF-Q180V Duodenoscopes ..http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00098-1
mdprc 026 02 16 000Verathon IncGlidescope Titanium Single-Use Video Laryngoscope Bladeshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00133-1
mdprc 096 01 16 000Varian Medical SystemsEclipse Treatment Planning System http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00064-1
mdprc 095 01 16 000Siemens Healthcare DiagnosticsADVIA 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 000Philips HealthcareIngenuity 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 000Philips HealthcareBrightView X/XCT/XCT http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00051-1
mdprc 091 01 16 000Mobilife Pty LtdSaline 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 000Leica Microsystems, Inc.PAX-5 Bond Ready-to-Use Primary Antibody Reagents Used with Bond Polymer Refine Detection Kitshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00069-1
mdprc 089 01 16 000Hill Rom IncLiko 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 000Fresenius Kabi LtdCurlin 6000 and Painsmart IOD http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00053-1
mdprc 058 01 16 001GE Healthcarefluoroscopic imaging systems http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00003-2
mdprc 063 01 16 000Siemens Healthcare Diagnostics ProductBCS / 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 000Murray International Trading Pty LtdOne Step HCG Urine Pregnancy Test http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00024-2
mdprc 059 01 16 000HeartWare IncHeartWare 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 000Abacus ALS Pty LtdEliA SmDP Well http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00013-2
mdprc 060 12 15 001Ethicon IncGynecare Thermachoice III Thermal Balloon Ablation Silicone Catheter http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142341
mdprc 082 05 15 001Resmed LimitedAstral 100, Astral 15http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00391-1
mdprc 024 01 16 000Trumpf 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 000Stryker CommunicationsVariAx 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 001St. Jude Medical IncRF 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 EX1150http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01335-1
mdprc 137 12 15 000SIEMENSAll 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 000Siemens Medical Solutions96 Deep Well Plate 2mL http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01257-1
mdprc 135 12 15 000Radiometer America IncTCM CombiM module http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01200-1
mdprc 134 12 15 000GE HealthcareAll Giraffe Carestation Beds http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01233-1
mdprc 133 12 15 000C R Bard Inc2-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 000Bio Rad.Dengue NS1 Ag Strip http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01238-1
mdprc 131 12 15 000Becton 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 000Accriva DiagnosticsVerifyNow Aspirin Test Kits Used with VerifyNow Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01252-1
mdprc 087 12 15 001Device Technologies Australia Pty LtdArcadophta SARL http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01229-1
mdprc 102 12 15 000Ambu IncAuraGain Disposable Laryngeal Maskshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01240-1
mdprc 101 12 15 000Philips HealthcareIntelliVie Information Centre (PIIC) iXhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01226-1
mdprc 004 12 15 001ConvaTecNebulisers / Nebuliser Mask ProductsMHRA
mdprc 076 12 15 000DePuySynthesPFN/PFNA Insertion Handle http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01211-1
mdprc 064 12 15 000Elekta CMS SoftwareMOSAIQ 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 000Biomet 3i IncMultiple 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 000Beckman CoulterUnicel 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 000Leica Microsystems Inc.Bond Polymer Refine Red Detection Kitshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01206-1
mdprc 059 12 15 000Diagnostic Solutions Pty LtdENA 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 000Boston ScientificACUITY Pro 9 Fr Guide Catheter http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01192-1
mdprc 057 12 15 000Bayer Healthcare LLCBayer 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 001bioMerieux IncEtest PIPTAZO PTC 256 http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01171-1
mdprc 126 11 15 001Siemens Medical SolutionsADVIA Centaur and ADVIA Centaur XP.. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01135-1
mdprc 110 11 15 001Siemens Medical SolutionsDimension Integrated Chemistry Systems. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01114-1
mdprc 015 12 15 000Biomet IncA.L.P.S. Cancellous Locking Screwshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01162-1
mdprc 014 12 15 000Siemens Medical Solutionssyngo 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 000KCI USA Inc300mL 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 000Kawasumi Laboratories IncMediRedi A.V. Fistula Pack http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01168-1
mdprc 003 12 15 000Brainlab AGBrainlab 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 000Independent Home Care & Surgical Supplies Pty LtdKarma Wheelchairs http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01157-1
mdprc 001 12 15 000bioCSL Pty LtdAbtectcell 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 000Terumo BCT IncA.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 000Siemens Medical SolutionsArtis systems with large display module http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01109-1
mdprc 106 09 15 001Roche Diagnostics CorpBulk Loader Module (BLM) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141086
mdprc 109 11 15 000QIAGEN Ltdartus C. trachomatis Plus kits http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01117-1
mdprc 108 11 15 000Beckman Coulter IncAU480, AU680, AU5800 Chemistry Analysers. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01044-1
mdprc 107 11 15 000Bard Pcripheral Vascular (BPV)ARCTIC SUN 5000 Temperature Management Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01116-1
mdprc 070 11 15 001LeMaitre Vascular GmbHLeMaitre Single Lumen Embolectomy Catheter 3F, 80 cmBfArM
mdprc 094 11 15 000Ortho-Clinical DiagnosticsVITROS 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 000Implant Direct LLCDGDE 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 000Device Technologies Australia Pty LtdArceole C3F8 and SF6 http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01106-1
mdprc 072 11 15 000Philips BurtonPhilips 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 000Masimo CorpRainbow 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 000CareFusion 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 000Becton 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 000Beckman Coulterichem VELOCITY Urine Chemistry Strips .. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01092-1
mdprc 047 11 15 000Prius Healthcare Solutions Pty LtdPrius Elite Bed http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01060-1
mdprc 046 11 15 000Carl Zeiss Meditec IncIOLMaster 500 http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01065-1
mdprc 045 11 15 000Baxter HealthcareVented Paclitaxel Sethttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01070-1
mdprc 013 11 15 001Medtronic IncAmphirion Deep Percutaneous Transluminal Angioplasty (PTA)MHRA
mdprc 026 11 15 000Siemens Medical SolutionsSOMATOM 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 000Beckman CoulterAccess free T3 Reagent kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01042-1
mdprc 014 11 15 000GE HealthcareRevolution CT Scanners http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01058-1
mdprc 012 11 15 000Physio Control IncLifePack 1000http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01036-1
mdprc 011 11 15 000Roche Diagnostics CorpBenchMark ULTRA & DISCOVERY ULTRAhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01032-1
mdprc 010 11 15 000Beckman CoulterAccess CEA Reagent Kit http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01035-1
mdprc 009 11 15 000Elekta IncMONACO system http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01023-1
mdprc 008 11 15 000Thermo Fisher Scientific OyQuidel Sofia Legionella FIA.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01034-1
mdprc 087 10 15 000Orthotech Pty LtdVaios Total Shoulder Replacement Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00976-1
mdprc 086 10 15 000Beckman Coulter IncAU480 Clinical Chemistry Analyserhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01011-1
mdprc 059 10 15 000Dickson & Dickson HealthcareOLS-500 & OLS-700 surgical lights http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00989-1
mdprc 058 10 15 000Philips HealthcareAllura Xper FD X-Ray Systems ...http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00995-1
mdprc 057 10 15 000Olympus Winter & IBE GmbHDisposable Myringotomy blade with handlehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-01002-1
mdprc 056 10 15 000Hospira IncPlum 360 Infusion Pumphttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00986-1
mdprc 028 10 15 000Stryker Howmedica Osteonics CorpDuracon Augmentshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00971-1
mdprc 027 10 15 000Ethicon Inc A Johnson & Johnson CoEthicon HARMONIC ACE+ 7 Laparoscopic Shears http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00994-1
mdprc 023 10 15 000Stryker 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 000Stryker Howmedica Osteonics CorpPCA 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 000Rehab Assist Pty LtdPrism 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 000Medtronic DiabetesMiniMed 640G insulin pump http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00968-1
mdprc 018 10 15 000GE HealthcareGiraffe Shuttle Products http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00927-1
mdprc 006 10 15 000Allergan Medical SAREFRESH 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 000Siemens Healthcare DiagnosticsAlkaline 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 000DePuySynthesSpecialist 2 Intramedullary Rod 400 mm Instrumentshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00956-1
mdprc 125 09 15 000Neoss Australia Pty LtdNeoss Guide http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00917-1
mdprc 124 09 15 000Medtronic IncMedtronic 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 000DePuySynthesSciatic Nerve Retractorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00938-1
mdprc 122 09 15 000Alba BioscienceAnti-Leb ALBAclonehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00898-1
mdprc 108 09 15 000Xcel Medical Solutions Pty LtdSuction Adapter Type A (Gauge)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00929-1
mdprc 107 09 15 000Teleflex 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 000Mathys Ltd BettlachseleXys TH+ and seleXys TPS acetabular shellshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00770-1
mdprc 104 09 15 000Elekta IncMonaco. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00910-1
mdprc 085 09 15 000Leica Biosystems Newcastle LtdNovocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagentshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00892-1
mdprc 076 09 15 000Stryker InstrumentsBase array component of the MAKO RIO Robotic Armhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00873-1
mdprc 075 09 15 000OlympusGF-UCT180 Ultrasonic Gastrovideoscopehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00909-1
mdprc 074 09 15 000Huntleigh Healthcare.Maxi Air Blower Unithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00859-1
mdprc 073 09 15 000William C. Domb, D.M.DCA1:1L EVO 15 http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00840-1
mdprc 041 09 15 001Stryker CommunicationsALIQUOT Delivery System Complete Set http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00843-1
mdprc 016 09 15 001Baxter HealthcareActifuse ABX and Actifuse MIS SystemMHRA
mdprc 044 09 15 000Terumo BCT IncSpectra Optia Apheresis System. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00862-1
mdprc 043 09 15 000Medtronic..CryoConsole Models http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00853-1
mdprc 042 09 15 000IRIS DiagnosticsiChem Velocity Urine Chemistry Strips. http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00806-1
mdprc 040 09 15 000Ethicon IncGYNEMESH PS & TVT Devices http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00743-1
mdprc 039 09 15 000Coloplast A/SColoplast 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 000Becton 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 000Edwards LifesciencesEdwards Pressure Monitoring Kit & Set http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00772-1
mdprc 018 09 15 000Covidien LLCMedi-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 000Bayer Healthcare LLCCONTOUR NEXT control solutions http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00746-1
mdprc 086 02 15 001Roche Diagnostics LtdElecsys CMV IgM assay (04784618190) - Diluent Universal.Swissmedic
mdprc 191 08 15 000Alcon Laboratories IncLX3 Microscope Floor Stand used with the LuxOR Ophthalmic Microscope and LuxOR Ophthalmic Microscope with Q-VUE 3D Assistant Visualisationhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00757-1
mdprc 166 08 15 000St. Jude Medical IncRF 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 EX1150http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00756-1
mdprc 165 08 15 000Philips BurtonBrilliance 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 000BMDi TUTA Healthcare Pty LtdExtension Set http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00719-1
mdprc 144 08 15 000Abbott Diabetes Care Div Abbott Laboratories IncFreeStyle 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 000Siemens Medical SolutionsArtis 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 000PerkinElmer Life and Analytical SciencesDELFIA Xpress PlGF Kit http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00629-1
mdprc 105 08 15 000GE HealthcareMR 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 000Philips BurtonSiesta i TS machine http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00707-1
mdprc 102 08 15 000Molnlycke Health Care ABWaratah 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 000Leica 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 000Intelerad 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 000DePuySynthesDePuy 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 000Becton 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 000Beckman Coulter IncUniCel DxC ISE Reference reagent tubing http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00697-1
mdprc 016 07 15 001Stryker InstrumentsStryker Sterile ImplantsBfArM
mdprc 066 08 15 000Unomedical A/SNeria Infusion Administration Sethttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00536-1
mdprc 065 08 15 000Smith & Nephew incSureshot Humeral 3.2mm AO Drillhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00689-1
mdprc 064 08 15 000SIEMENSAcuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ optionhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00595-1
mdprc 063 08 15 000Siemens Medical SolutionsACUSON S Family Ultrasound Systems utilising the 18L6 HD and/or 6C1 HD biopsy guidelineshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00609-1
mdprc 062 08 15 000SIEMENSArtis systems with SW version VC14Jhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00612-1
mdprc 061 08 15 000Radiometer MedicalMicroGas 7650 Operator Manual used with Radiometer MicroGas 7650 Transcutaneous Monitorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00617-1
mdprc 060 08 15 000Ortho-Clinical DiagnosticsVITROS 5,1 FS Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00607-1
mdprc 059 08 15 000ITL HealthcareBack Table Cover supplied in a limited range of Operating Room Packshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00686-1
mdprc 058 08 15 000Elekta CMS SoftwareMOSAIQ Release 2.41 and higherhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00608-1
mdprc 121 06 15 001bioMerieux IncCEFOTAXIME CT 256 WW F100.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00516-1
mdprc 020 07 15 000Trumpf Medical Systems, Inc.Ceiling Supply Unit klinoPORThttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00590-1
mdprc 019 07 15 000Siemens Medical SolutionsADVIA 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 000Philips BurtonSENSE Body Coil 1.5T Used with ACS NT, Achieva 1.5T, and Intera 1.5T Magnetic Resonance Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00584-1
mdprc 017 07 15 000Philips BurtonPhilips HeartStart XL+http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00588-1
mdprc 015 07 15 000Philips HealthcareMasimo uSpO2 and HPLP Oximetry Cableshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00542-1
mdprc 014 07 15 000bioMerieux IncParechovirus r-genehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00579-1
mdprc 013 07 15 000Abbott Laboratories Inci-STAT PT/INR Cartridgeshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00549-1
mdprc 009 07 15 000Koala Medical Pty LtdPaediatric Anaesthetic Breathing Circuit with Swivel Wyehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00552-1
mdprc 008 07 15 000AMS USAReusable Stripper and Cleaver Accessories Used with Aura Fibershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00570-1
mdprc 155 06 15 000ConvaTecSuction Tubehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00514-1
mdprc 154 06 15 000TopconTOPCON – 3D Optical Coherence Tomography 3D OCT-1 MAESTRO machineshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00517-1
mdprc 153 06 15 000Cook MedicalLunderquist Extra-Stiff Wire Guidehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00545-1
mdprc 152 06 15 000Argon Medical Devices IncARGON Bone Marrow I-type aspirate/biopsy needles & ARGON Trap-Lok Bone Marrow biopsy needleshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00541-1
mdprc 122 06 15 000SIEMENSImmulite (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 000Beckman CoulterAccess 2 Immunoassay Systems.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00488-1
mdprc 098 06 15 000Roche Diagnostics CorpTina-quant Soluble Transferrin Receptor (STFR): Elevated imprecision with QC Level 1http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00499-1
mdprc 097 06 15 000Philips HealthcareUltrasound Q-Stationhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00491-1
mdprc 096 06 15 000NDIDisposable Reflective Marker Sphereshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00502-1
mdprc 073 06 15 000Verathon IncGlideScope Reusable Video Laryngoscope Bladeshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00461-1
mdprc 072 06 15 000Siemens Medical SolutionsArtis zee Floorstand, Artis zee Biplane Floorstand and Artis zee Multi Purpose systems with SW version VC21Bhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00483-1
mdprc 071 06 15 000Roche Diagnostics CorpRoche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) reactionhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00463-1
mdprc 070 06 15 000Ortho-Clinical DiagnosticsVITROS 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 000Bausch & Lomb Contact LensesSofPort Advanced Optics Aspheric IOL, Model LI61AOhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00477-1
mdprc 068 06 15 000Bard Access SystemsBard Per-Q-Cath line of productshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00480-1
mdprc 035 06 15 000Smiths 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 000Varian Medical SystemsSurface 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 000Siemens Medical SolutionsADVIA Centaur TnI-Ultra http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00442-1
mdprc 032 06 15 000Siemens Medical Solutionssyngo 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 000SIEMENSBerichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i and CS-5100 instrumentshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00426-1
mdprc 012 06 15 000Siemens Healthcare Diagnostics GmbHDimension Vista 500 and 1500 Intelligent Lab Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00430-1
mdprc 011 06 15 000Philips BurtonFlexTEMP Temperature Sensors Used with Expression MRI Patient Monitoring Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00425-1
mdprc 010 06 15 000PerkinElmer Life and Analytical SciencesWIZARD2 Gamma Countershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00417-1
mdprc 009 06 15 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostic Products NT-proBNP Calibrators and Reagent Packshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00427-1
mdprc 008 06 15 000OMNIlife scienceApex 10mm reamerhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00419-1
mdprc 140 05 15 000Animas Corporation .Animas 2020 and Animas IR 1200http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00363-1
mdprc 139 05 15 000Medtronic IncVarious Shiley Tracheostomy Tubeshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00412-1
mdprc 138 05 15 000Device Technologies Australia Pty LtdMicrotek 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 000Emergo Asia Pacific Pty Ltd T/a Emergo AustraliaIntelePACS http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00404-1
mdprc 136 05 15 000Philips HealthcarePhilips Model AFFINITI 70 Ultrasound System without Pediatric Cardiology optionhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00409-1
mdprc 135 05 15 000SIEMENSImmulite 2000 and Immulite 2000 XPi – Italian Cypress Allergenhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00401-1
mdprc 134 05 15 000SIEMENSCios Alpha mobile C-arm x-ray systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00399-1
mdprc 133 05 15 000Siemens Healthcare DiagnosticsRAPIDLab Blood Gas Analyzershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00416-1
mdprc 079 05 15 001HeartWare IncHeartWare HVAD System ..http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00370-1
mdprc 081 05 15 000OlympusDiego Elite Tubesetshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00397-1
mdprc 080 05 15 000Medline Industries IncMedline Procedure Packs containing Covidien Devon Light Gloveshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00395-1
mdprc 078 05 15 000Device Technologies Australia Pty LtdCorpatch Easy Paediatrichttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00388-1
mdprc 077 05 15 000Thermo Fisher Scientific Inc.Remel PathoDx Strep B Group Latexhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00380-1
mdprc 049 06 14 001SIEMENSARTISTE, ONCOR and PRIMUS with Automatic Sequenced Treatment Delivery Optionhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00614-1
mdprc 039 05 15 000Helena LaboratoriesOPTI Blood Gas analysers http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00367-1
mdprc 024 05 15 000CovidienDevon Light Gloveshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00364-1
mdprc 023 05 15 000Invacare CorporationInvacare TDX series and Storm Series power wheelchairshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00356-1
mdprc 146 04 15 000SIEMENSDimension 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 000SonoSite IncSonoSitePowerPark 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 000Siemens Medical SolutionsAmylase Assay used with ADVIA Chemistry Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00340-1
mdprc 121 04 15 000Groupon Australia Pty LtdCounterfeit Durex branded condoms purchased from Groupon websitehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00346-1
mdprc 120 04 15 000Fisher & Paykel Healthcare LimitedHarris Oxygen Flowmeterhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00266-1
mdprc 095 04 15 000Baxter HealthcareBaxter Irrigation solutionshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00329-1
mdprc 094 04 15 000Bio-Rad Laboratories IncID-LISS/Coombs Cards.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00314-1
mdprc 093 04 15 000Device Technologies Australia Pty LtdSTERIS Caviwave Pro Ultrasonic Cleaning Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00323-1
mdprc 092 04 15 000ELITech Group SASDako Beta-2-Microglobulin PET Kits.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00331-1
mdprc 091 04 15 000Karl Storz GmbH & Co KGKarl Storz Tissue Morcellation Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00310-1
mdprc 090 04 15 000Ortho-Clinical DiagnosticsVITROS Chemistry Systems.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00326-1
mdprc 089 04 15 000Ortho-Clinical DiagnosticsenGen Laboratory Automation Systems ..http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00328-1
mdprc 088 04 15 000Specsavers Pty LtdEasyvision 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 000Solaris Medical TechnologyAegis Standing Slinghttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00308-1
mdprc 049 07 14 001PerkinElmer Life and Analytical SciencesPanthera-Puncher 9http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00714-1
mdprc 038 04 15 000CareFusionAlaris PC unitshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00289-1
mdprc 037 04 15 000DePuySynthesCross-Link Clamp for Rods, 6.0 mmhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00290-1
mdprc 007 04 15 000Stryker InstrumentsCBCII 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 000Radiometer MedicalRadiometer immunoassay AQT90FLEX Analyserhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00273-1
mdprc 005 04 15 000K Care Pty LtdMy Mobility Walking Frame with Front Wheelshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00277-1
mdprc 004 04 15 000Covidien LLCCovidien Trellis 6 and Trellis 8 Peripheral Infusion Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00267-1
mdprc 003 04 15 000Bard CONQUEST PTA Dilatation Cathetershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00286-1
mdprc 002 04 15 000Alere International LimitedCaptia Malaria EIAhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00275-1
mdprc 013 03 15 001Becton Dickinson & Co. (BD)BD Q-Syte Luer Access Split Septum Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134096
mdprc 121 03 15 000Transonic Systems IncTransonic Hemodialysis Monitorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00183-1
mdprc 120 03 15 000RQSolutions Medical Devices Distribution SupportMETAL SHELL, CEM.LESS ‘DeltaLox’ SCREW FIX., TiNb-COAThttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00210-1
mdprc 119 03 15 000Roche Diagnostics CorpCobas c 501 / c 502 and COBAS INTEGRAhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00229-1
mdprc 118 03 15 000Philips HealthcareBrilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity Elite and Ingenuity CThttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00212-1
mdprc 117 03 15 000GE HealthcareModel T2100 Treadmillshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00259-1
mdprc 116 03 15 000Diversey Australia Pty LtdDivercleanse 750ml http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00262-1
mdprc 115 03 15 000AngioDynamicsMorpheus Smart CT PICC Kitshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00263-1
mdprc 114 03 15 000AMO Manufacturing Catalys Precision Laser Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00240-1
mdprc 150 12 13 001Fresenius Kabi LtdCompoStop 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 000Siemens Healthcare Diagnostics IMMULITE 2000/IMMULITE 2000 Xpihttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00201-1
mdprc 084 03 15 000Ortho-Clinical DiagnosticsVITROS 5,1 FS Chemistry Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00214-1
mdprc 083 03 15 000Getinge Disinfection Getinge 46 Serieshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00174-1
mdprc 082 03 15 000BrainLABEXACTRAC 6.xhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00204-1
mdprc 059 04 14 001GE HealthcareKenex suspension arm with radiation shield and/or surgical lamphttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00407-1
mdprc 044 03 15 000Whiteley Corporation Pty LtdSonidet – Medical Equipment & Instrument Detergenthttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00186-1
mdprc 043 03 15 000Edwards LifesciencesEdwards Lifesciences Heart Reference Sensor ( HRS)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00162-1
mdprc 100 02 15 001Philips BurtonAllura Xper R7.2.xhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00122-1
mdprc 021 03 15 000Kerr CorpCure Sleevehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00173-1
mdprc 020 03 15 000Defries Industries Pty LtdPVC TUBING X-RAYhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00170-1
mdprc 015 03 15 000Stryker OrthopaedicsTriathlon Distal Capture Assemblieshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00140-1
mdprc 014 03 15 000Stryker OrthopaedicsLFIT V40 Femoral Headshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00129-1
mdprc 121 02 15 000Siemens Healthcare Diagnostics ProductIMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive Biashttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00131-1
mdprc 111 02 15 000GRC Surgical Pty LtdLiNA Xcise Laparoscopic Morcellatorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00119-1
mdprc 110 02 15 000GE HealthcareT2100 and T2000 Treadmill power cordshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00128-1
mdprc 155 12 14 001Radiometer America IncRadiometer ABL90Flex analysershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00124-1
mdprc 099 02 15 000MedicinaMedicina Orange Enteral Feeding Pumphttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00125-1
mdprc 098 02 15 000Australian Orthotic Technologies Pty LtdAirlight ROM bracehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00090-1
mdprc 089 02 15 000Endocorp Pty LtdMorce Power Plus 2307http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00107-1
mdprc 088 02 15 000Thermo Fisher Scientific Microbiology Perth incOxoid 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 000OlympusOlympushttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00112-1
mdprc 084 02 15 000GE HealthcareProteus XR/a X-ray imaging systems manufactured with wall standhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00116-1
mdprc 034 02 15 001Zimmer incVarious Femoral Headshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00029-1
mdprc 055 02 15 000Spacelabs Healthcare Incqube Compact Monitor & XPREZZON Bedside Monitorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00104-1
mdprc 054 02 15 000Philips Medical SystemsAllura Systems: Field extensions Vascular R7.6http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00105-1
mdprc 053 02 15 000Biomet IncM2a 38 Acetabular Cup, M2a 38 Femoral Head, M2a Magnum Tri-Spike Acetabular Cup & M2a Magnum Femoral Headshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00100-1
mdprc 042 02 15 000Philips BurtonDuraDiagnost X-ray System.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00089-1
mdprc 037 02 15 000Roche Diagnostics CorpCobas EGFR MutationTest Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00091-1
mdprc 036 02 15 000GambroAK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machineshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00093-1
mdprc 035 02 15 000bioMerieux IncVITEK 2 System version 7.01.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00096-1
mdprc 033 02 15 000Smiths Medical ASD Inc..CADD Medication Cassette Reservoir, 50mlhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00081-1
mdprc 032 02 15 000Simavita Aust Pty LtdSIM System with SIM dock power supply model Franmar FRA012-S05-Ihttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00076-1
mdprc 031 02 15 000Siemens Healthcare DiagnosticsSiemens Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillarieshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00084-1
mdprc 030 02 15 000Siemens Healthcare Diagnostics ProductADVIA 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 000Covidien LLCPuritan Bennett 980 Series Ventilator System..http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00048-1
mdprc 151 12 14 001Covidien LLCTrellis 8 Peripheral Infusion Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132204
mdprc 089 01 15 001Siemens Medical Solutionssyngo.plaza http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133015
mdprc 121 01 15 000Carl Zeiss Meditec IncFORUM Software http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00051-1
mdprc 112 01 15 001Stryker CommunicationsSystem 6 Aseptic Battery Kithttp://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/43389r-eng.php
mdprc 152 12 14 001Diagnostic Solutions Pty LtdPF4 IgG assay (Thrombophilia and coagulation inhibitor assay)Swissmedic
mdprc 095 01 15 000Zimmer incPersona TASP Shimshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00013-1
mdprc 094 01 15 000Sony ElectronicsSONY LMD-1951MD MONITORShttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00032-1
mdprc 093 01 15 000Smiths Medical IncSingle Limb Circuit for Pneupac Ventilators, with PEEP Valvehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00047-1
mdprc 092 01 15 000Siemens Medical SolutionsACUSON SC2000 ultrasound systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00035-1
mdprc 091 01 15 000MedicinaMedicina SILOBAGhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00043-1
mdprc 088 01 15 000Ortho-Clinical DiagnosticsHand?held Barcode Scanner used with VTROS clinical chemistry systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00033-1
mdprc 075 01 15 000Intrinsic Therapeutics IncProsthesis, internal, spine, dischttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00002-1
mdprc 094 06 14 001GE HealthcareProteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging systemsMHRA
mdprc 161 12 14 001Leica Microsystems, Inc.NCL-L-CD15.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01357-1
mdprc 160 12 14 000Synthes IncCheek Retractor, f/MatrixMANDIBLE U-shaped, flexiblehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01366-1
mdprc 159 12 14 000Synthes IncBending/Cutting Pliers with Nosehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01359-1
mdprc 157 12 14 000St. Jude Medical IncSensei X Robotic Catheter Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01325-1
mdprc 156 12 14 000Siemens Medical SolutionsDigital 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 000Medline International Two Australia Pty LtdMinor Plastics Pack IVF Australiahttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01360-1
mdprc 153 12 14 000Elekta LimitedFocal Release 4.80.00http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01356-1
mdprc 150 12 14 000Beckman CoulterEnzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase Analyteshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01350-1
mdprc 052 02 14 001ThermoFisher 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 000GI Dynamics IncEndoBarrier Gastrointestinal Liner with Delivery Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01320-1
mdprc 065 10 14 001Covidien LLCPuritan Bennett 980 Series Ventilator System.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01326-1
mdprc 111 12 14 000SIEMENSArtis Q and Q.zen Ceiling Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01307-1
mdprc 110 12 14 000Radiometer America IncAQT90Flex TnI (troponin) Test Kit.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01304-1
mdprc 109 12 14 000BrainLAB El SeifiPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localiser and one of the positioning solutions Target Positionerhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01293-1
mdprc 108 12 14 000AlereCaptia Malaria EIAhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01315-1
mdprc 107 12 14 000Alere LTDAlere Actim Partushttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01323-1
mdprc 101 12 14 000Fisher & Paykel Healthcare LimitedIW900-series Infant Warmershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01188-1
mdprc 085 12 14 000Zimmer incTrilogy Bone Screwshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01271-1
mdprc 084 12 14 000Tornier IncHumeral 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 000QIAGEN LtdQIAsymphony DSP Virus/Pathogen Midi Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01281-1
mdprc 082 12 14 000DePuySynthesSmall Electric Drivehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01278-1
mdprc 081 12 14 000AlereAlere INRatio PT/INR Monitor Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01289-1
mdprc 051 12 14 000Philips HealthcarePhilips HeartStart MRx Monitor/Defibrillatorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01268-1
mdprc 050 12 14 000Stryker EndoscopyLaparoscopic Manual Instruments and Accessorieshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01264-1
mdprc 049 12 14 000IQ Medicali-Optics’ Cassinihttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01265-1
mdprc 048 12 14 000GE HealthcareDefibrillation Electrode for Children (Leonhard Lang) used with GE defibrillatorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01266-1
mdprc 047 12 14 000Biomet Biomet Orthopedics (“Biomet”) Sirius Polish Cemented Stemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01270-1
mdprc 025 12 14 001Philips Medizin Systeme GmbHBrightView SPECT, BrightView X and BrightView XCT Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01224-1
mdprc 026 12 14 000ScottCare CorpFAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kitshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01234-1
mdprc 024 12 14 000Kimberly Clark Health CareKimVent Microcuff Subglottic Suctioning Endotracheal Tubehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01242-1
mdprc 023 12 14 000Carl Zeiss Meditec IncLumaDent Light Battery Packshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01248-1
mdprc 018 12 14 000Vision RTAlignRT patient positioninghttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01220-1
mdprc 017 12 14 000Siemens Medical Solutionssyngo Imaging XS and syngo.plazahttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01235-1
mdprc 016 12 14 000Siemens Healthcare Diagnostics ProductIMMULITE 2000 and IMMULITE 2000 Xpihttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01238-1
mdprc 015 12 14 000Radiometer America IncPico 70 Arterial Blood samplerhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01236-1
mdprc 014 12 14 000Philips Healthcare Gamma CamerasBrightView XCT SPECT/CT systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01226-1
mdprc 013 12 14 000Medtronic IncCareLink Clinical Therapy Management Softwarehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01215-1
mdprc 012 12 14 000Kerr (USA) Div Sybron Dental Specialties IncSilanehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01241-1
mdprc 011 12 14 000DiaSorin IncLIAISON Borrelia IgGhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01240-1
mdprc 010 12 14 000Covidien LLCMcGRATH MAC Video Laryngoscope Blade Size #2http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01239-1
mdprc 009 12 14 000Boston ScientificBoston 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 002HemoCue A BHemoCue Glucose 201 Microcuvettes single packedhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01197-1
mdprc 087 11 14 000Bausch & Lomb Inc.Stellaris PC with Laser Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01205-1
mdprc 086 11 14 000CovidienGelflex Sterile Eye Wash Normal Saline 10mL Ampoulehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01130-1
mdprc 085 11 14 000GambroRevaclear and Revaclear Max Dialyzershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01214-1
mdprc 083 11 14 000Radiometer MedicalcCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser rangehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01201-1
mdprc 082 11 14 000Siemens Healthcare Diagnostics GmbHDimension Vista 500 Intelligent Lab System & Dimension Vista 1500 Intelligent Lab Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01192-1
mdprc 081 11 14 000Smith & Nephew OrthopaedicArthroCare Corporation HipVac 50 Coblation Wandhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01203-1
mdprc 192 08 13 001Biomet 3i IncNavigator Surgical Kit/Tray, Tapered Navigator Surgical Kit/Tray, Contra-Angle Torque Driver Kit, Prosthetic Instrumentation Kit, Prosthetic System Driver Trayhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00895-1
mdprc 046 10 13 001StrykerADM/MDM Ball Impactor Tips and ADM Rim Impactor Tipshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01033-1
mdprc 073 07 13 001GE Healthcarenuclear medicine systems, Infinia nuclear medicine systems, VG and VG Hawkeye nuclear medicine systems and Helix nuclear medicine systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00695-1
mdprc 048 11 14 000Mindray DS USA, Inc., dba Datascope Patient MonitoringMindray's V-Series Patient Monitorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01173-1
mdprc 047 11 14 000Philips HealthcareMammoDiagnost DRhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01180-1
mdprc 046 11 14 000Oxoid Div ThermoFisher Scientific Microbiology Anaerobic Agar Platehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01164-1
mdprc 045 11 14 000Mindray DS USA, Inc., dba Datascope Patient MonitoringMindray V-Series Patient Monitors with 12-lead ECG interpretation capabilitieshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01172-1
mdprc 044 11 14 000Intuitive Surgical IncEndo Wrist One Vessel Sealer (INS-410322) for the da Vinci Si (IS3000) Surgical Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01174-1
mdprc 023 11 14 000Oxoid Div ThermoFisher Scientific Microbiology PerthThioglycollate Broth 5mL.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01152-1
mdprc 017 11 14 000Zimmer incNexGen Trabecular Metal Tibial Replacement Impactor Pads Contained in Trayshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01170-1
mdprc 016 11 14 000Roche Diagnostics GmbHAFB III Staining Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01161-1
mdprc 015 11 14 000Biosense 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 000Edwards LifesciencesEdwards Lifesciences Vent Catheterhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01106-1
mdprc 113 10 14 000Siemens Healthcare Diagnostics ProductIMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi - Calcitonin Control Modulehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01133-1
mdprc 112 10 14 0003M UNITEK CorporationAPC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hookhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01135-1
mdprc 103 09 14 001Siemens Healthcare DiagnosticsADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) Assayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130181
mdprc 096 10 14 000Hospira IncSapphire 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 000Biomet Microfixation50mm Left Standard Ti Mandiblehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01132-1
mdprc 089 10 14 000Siemens Healthcare DiagnosticsADVIA Centaur and ADVIA Centaur XPhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01116-1
mdprc 088 10 14 000Pfizer LimitedDimetapp Saline Nasal Drops for Infantshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01036-1
mdprc 116 09 14 002CovidienCovidienMedi-Trace Cadence Defibrillation Electrodeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130112
mdprc 068 10 14 000Teleflex MedicalHudson Nebuliser Adaptor - AQUAPAKhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01103-1
mdprc 067 10 14 000Beckman CoulterSmall Form Factor Console PChttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01087-1
mdprc 066 10 14 000Integra LifeSciencesSelector Tubing Kits Used with CUSA Ultrasonic Aspiratorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01079-1
mdprc 044 10 14 000GE HealthcareOEC 9800, OEC UroView 2800, OEC MiniView 6800, OEC FlexiView 8800http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01072-1
mdprc 043 10 14 000Siemens Healthcare DiagnosticsADVIA 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 000Siemens Healthcare DiagnosticsCLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01062-1
mdprc 041 10 14 000Molnlycke Health Care ABMicrotek Basin Liners Contained in Molynlycke ProcedurePakshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01082-1
mdprc 040 10 14 000IMRISIMRIS Operating Room table (ORT300)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01078-1
mdprc 039 10 14 000GE HealthcareDiscovery MR750 and Discovery MR750whttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01067-1
mdprc 037 10 14 000Covidien LLCPuritan Bennett 980 Series Ventilator Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01088-1
mdprc 036 10 14 000Bard Access SystemsLifemed Urinary Drainage Bag with Pumphttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01058-1
mdprc 035 10 14 000Amplitude GmbHAMPLITUDE Orthopaedic Surgical Instrumentshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01059-1
mdprc 034 10 14 000Abbott Laboratories IncAbbott RealTime Assay Application CD-ROMhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01076-1
mdprc 030 09 14 002ZOLL Medical CorpZOLL ProPadz Sterile Multi-Function Electrodeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130465
mdprc 026 10 14 000Roche Diagnostics GmbHAccu-Chek Spirit Combo Insulin Pumpshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01063-1
mdprc 025 10 14 000CooperVision Inc.Proclear Toric Soft Hydrophilic Contact Lenseshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01039-1
mdprc 005 10 14 000Zimmer incPersona 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 000SIEMENSArtis zee and Artiszeego systems used in conjunction with the A100 generator and specific lots of X-ray tubehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01035-1
mdprc 119 09 14 000Siemens Healthcare Diagnostics ProductIMMULITE/IMMULITE 1000 - Cortisol Assayhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01023-1
mdprc 118 09 14 000Siemens Healthcare Diagnostics GmbHDimension Vista Hemoglobin A1c Flex Reagent Cartridgehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01030-1
mdprc 117 09 14 000MedionGrifols Diagnostics AGGrifols Australia Perfect Panel cellshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01020-1
mdprc 115 09 14 000Covidien LLCAeroneb Pro and Solo Nebuliser Systems - FRIWO power adapterhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01038-1
mdprc 102 09 14 000Codman & Shurtleff IncCodman Neuro EDS 3 CSF External Drainage Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01009-1
mdprc 028 09 13 001Boston Scientific LtdCOGNIS 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 000Alcon Laboratories IncAcrySof CACHET PHAKIC Lenshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01013-1
mdprc 100 09 14 000Abbott Diagnostic International Ltdm24sp Instrument System.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01010-1
mdprc 082 09 14 000Bio-Rad Laboratories IncNaCl, Enzyme Test and Cold Agglutininshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01000-1
mdprc 081 09 14 000Ortho-Clinical DiagnosticsVITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems Using Software Version 3.0http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01001-1
mdprc 030 08 14 001GE HealthcareDiscovery XR656 Wall Stand Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00834-1
mdprc 071 09 14 000Siemens Healthcare Diagnostics ProductDade Innovin (Prothrombin time assay)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00873-1
mdprc 070 09 14 000bioCSL Pty LtdPhenocell A 3%http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00986-1
mdprc 068 09 14 000Device Technologies Australia Pty LtdDefibrillator/pacer SLIM corpuls3http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00979-1
mdprc 047 06 14 001Covidien LLCPuritan Bennett 840 Ventilatorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00974-1
mdprc 137 07 14 001Stryker EndoscopyAVS ARIA Implant Inserterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129150
mdprc 051 09 14 000Mckesson Information Solutions LLCHorizon Cardiology Hemohttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00962-1
mdprc 020 09 14 001Synthes IncCortex Screw Ø 3.5 mm, self-tapping, length 28 mm, Stainless SteelSwissmedic
mdprc 043 09 14 000Terumo BCT IncSpectra Optia Apheresis System with Software Version 11http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00963-1
mdprc 042 09 14 000bioCSL Pty LtdPhenocell A 3%http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00951-1
mdprc 032 09 14 000Vision-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 000Johnson & Johnson Medical GmbHOmrix Pressure Regulator.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00937-1
mdprc 117 08 14 001St. Jude Medical IncSt. 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 001ArjoHuntleighMinstrel Patient Transfer Lift with ScaleBfArM
mdprc 019 09 14 000SIEMENSV5Ms transesophageal transducerhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00943-1
mdprc 018 09 14 000Bard Pcripheral Vascular (BPV)Bard DuaLok Breast Lesion Localization Wirehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00946-1
mdprc 005 09 14 000Wright 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 000Vapotherm IncVapotherm Disposable Patient Circuit Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00916-1
mdprc 003 09 14 000Terumo BCT IncSpectra 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 000Siemens Healthcare DiagnosticsADVIA Centaur and ADVIA Centaur XP Immunoassay Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00925-1
mdprc 129 10 13 001Zimmer incTrinica Ratchet Handles, Non-active implantable deviceshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01092-1
mdprc 116 08 14 000Getinge Disinfection ABHS66 Turbo LTSF Steriliserhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00908-1
mdprc 034 08 14 001Siemens Healthcare Diagnostics ProductSysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysersBfArM
mdprc 049 05 14 002HeartWare IncHeartWare Ventricular Assist System batterieshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00902-1
mdprc 024 12 13 002Beckman CoulterUniCel DxH 600 and DxH 800 Cellular Analysis Systems.BfArM
mdprc 073 08 14 000Steris CorpSTERIS 4085, 4085 SS and 4085 Feather Weight Leg Section (FLWS) Surgical tableshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00884-1
mdprc 072 08 14 000SIEMENSChemistry 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 000SIEMENSSymbia T Series and Symbia Intevo Camera Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00881-1
mdprc 070 08 14 000Olympus Winter & IBE GmbHProcessor 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 Centerhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00859-1
mdprc 136 03 14 001MAQUET Cardiovascular LLCIntra-Aortic Balloon Pumps (IABP)BfArM
mdprc 052 08 14 000Oxoid LtdShigella 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 000St. Jude Medical Inc..AGA Medical Amplatzer Septal Occluderhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00609-1
mdprc 033 08 14 000Philips HealthcarePhilips Ultrasound QLABhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00837-1
mdprc 032 08 14 000Bio Rad.Amoxicillin + clavulanic acid diskshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00856-1
mdprc 031 08 14 000Standard DignosticsPanbio Q Fever IgM ELISAhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00792-1
mdprc 138 07 14 000William Cook Europe ApSTXR-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 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00820-1
mdprc 135 07 14 000In Vitro TechnologiesCooper Surgical TransWarmer Infant Transport Mattresshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00801-1
mdprc 125 06 14 001Williams Medical Supplies LtdSkin Graft Knife Blades for use with Thackray Watson Cobbett and Braithwaite Skin Graft Knifehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00654-1
mdprc 065 07 14 001Molnlycke Health Care ABProcedurePakhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00768-1
mdprc 048 07 14 001Becton 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 001Synthes IncApplication Instrument for Sternal ZipFixhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00924-1
mdprc 089 07 14 000Stryker Instruments ( Ultrasonic Surgical Aspirator System )Sonopet Consolehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00769-1
mdprc 088 07 14 000SIEMENSArtis Q and Artis Q zen systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00782-1
mdprc 087 07 14 000BrainLABBrainlab Patient Data Managerhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00784-1
mdprc 137 03 14 001Stryker CommunicationsShape Arm Kit Left and Shape Arm Kit Righthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126388
mdprc 067 07 14 000Philips HealthcareMobileDiagnost wDR.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00762-1
mdprc 066 07 14 000Ortho-Clinical DiagnosticsVITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00765-1
mdprc 064 07 14 000Device Technologies Australia Pty LtdSpecular Microscope SP-1Phttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00771-1
mdprc 063 07 14 000Abbott Molecular Inc Sub Abbott Laboratories5mL Reaction Vessels used with the m2000sp Instrumenthttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00764-1
mdprc 060 07 14 000Instrumentation LaboratoryACL 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 001Philips HealthcareIngenia, Intera and Achieva MR Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00577-1
mdprc 055 07 14 000Stryker MedicalInTouch Critical Care Bedhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00727-1
mdprc 054 07 14 000Oxoid Div ThermoFisher Scientific Microbiology PerthThioglycollate Mediumhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00728-1
mdprc 053 07 14 000Mckesson Information Solutions LLCHorizon Cardiology Hemo1http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00735-1
mdprc 052 07 14 000Hill Rom IncAffinity Four Birthing Bedhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00713-1
mdprc 051 07 14 000Device Technologies Australia Pty LtdSlide-in Plug Adaptor for Chargerhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00736-1
mdprc 050 07 14 000Siemens Healthcare DiagnosticsRAPIDQC Complete Quality Control Materialhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00702-1
mdprc 047 07 14 000Abbott Molecular Inc Sub Abbott Laboratoriesm24sp Instrument Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00708-1
mdprc 119 11 13 002Atrium Medical CorporationAtrium 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 000Linear Medical Pty LtdLancet, Low Flow and Micro Flowhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00695-1
mdprc 034 07 14 000Clifford HallamCrepe Bandagehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00688-1
mdprc 005 07 14 000Mayo Healthcare Pty LtdMulti Lumen and Pressure Injectable Central Venous Cathetershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00613-1
mdprc 004 07 14 000AGFA Corp.DX-D 100 Digital Radiography X-Ray Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00674-1
mdprc 043 04 14 001GE HealthcareOEC 9900 Workstation Monitor Spring Arm Screwshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00389-1
mdprc 123 06 14 000Intelerad Medical Systems Inc.INTELEPACShttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00662-1
mdprc 122 06 14 000Better Living care500 Series Vertical Railshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00602-1
mdprc 029 09 13 001Nipro CorpPSV Sets (Scalp Vein), Hard, 27Gx 3/4" ISO CEhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00302-1
mdprc 098 06 14 000Siemens Medical SolutionsAxiom Artis and Artis Zee Systems with hand switchhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00648-1
mdprc 097 06 14 000DePuySynthesCortex Screw Ø 1.5 mm, self-tapping, length 8 mmhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00646-1
mdprc 096 06 14 000Covidien LLCPuritan Bennett 840 Ventilator.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00653-1
mdprc 095 06 14 000Medtronic NeuromodulationMedtronic Duet External Drainage and Monitoring Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00631-1
mdprc 093 06 14 000Bio-Rad Laboratories IncD-10 Haemoglobin Testing Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00280-1
mdprc 065 06 14 000Siemens Healthcare Diagnostics ProductRIA Coat A Count Androstenedionehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00624-1
mdprc 064 06 14 000Philips HealthcareIngenia MR FlexTrak Trolleyhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00623-1
mdprc 050 06 14 000Mentor Medical SystemsMENTOR Gel Sizershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00600-1
mdprc 048 06 14 000Siemens Healthcare DiagnosticsADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CPhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00608-1
mdprc 046 06 14 000Alere San DiegoAlere Triage BNP Calibratorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00619-1
mdprc 025 05 14 001Arrow International IncPercutaneous Sheath Introducer Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126904
mdprc 035 06 14 000Stryker CommunicationsMultiple Burs and Drillshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00593-1
mdprc 033 06 14 000Mckesson Medical Imaging GroupHorizon Medical Imaging productshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00610-1
mdprc 032 06 14 000Life HealthcareVTI Bayonet 20 MHz Doppler Probehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00607-1
mdprc 031 06 14 000Kerr CorpTytin Regular Set (Dental Amalgam)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00606-1
mdprc 030 06 14 000Becton Dickinson & Co. (BD)BBL Crystal Enteric/Nonfermenter ID Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00599-1
mdprc 016 04 14 002Alere San DiegoAlere Triage BNP Test for Beckman Coulterhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00374-1
mdprc 076 01 14 002Leica Biosystems Newcastle LtdNovocastra Liquid Mouse Monoclonal Antibody http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126925
mdprc 110 12 13 001Hospira IncINFUSION PUMP, PLUM LifeCare 5000 Series and PLUM XL Families of Infusers Broken Door Roller Assemblyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125503
mdprc 052 05 14 001Siemens Healthcare Diagnostics GmbHADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CPhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126652
mdprc 008 06 14 000Roche Diagnostics GmbHAccu-Chek Mobile Blood Glucose Meterhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00592-1
mdprc 006 06 14 000SIEMENSACUSON S2000 and ACUSON S3000 Ultrasound Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00563-1
mdprc 004 06 14 000Draeger Medical Systems IncDisposable Ventstar 180cm Circuithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00567-1
mdprc 141 05 14 000Biosense Webster Inc ThermoCool SF NAV Catheter Familyhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00588-1
mdprc 136 05 14 000Invacare CorporationMobile Shower and Toilet Commode Aquatec Ocean VIPhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00518-1
mdprc 135 05 14 000St. Jude Medical IncAxium Neurostimulator Leadshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00531-1
mdprc 134 05 14 000REM SystemsPolyurethane Nasogastric Feeding Tubehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00561-1
mdprc 133 05 14 000Philips HealthcareBattery Packs used with SmartMonitor 2 Professional Series Monitorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00585-1
mdprc 131 05 14 000Beckman CoulterUltrasonic Transducer Kits used with the Access Family of Immunoassay Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00562-1
mdprc 130 05 14 000Baxter HealthcareBaxter Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshellhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00568-1
mdprc 085 02 14 001SIEMENSAXIOM Artis Systems.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00136-1
mdprc 047 05 14 001AlereAlere INRatio2 PT/INR Heparin Insensitive Test StripsBfArM
mdprc 097 05 14 000GE HealthcareSingle-width Airway Module E-miniC and Extension Modules N-FC & N-FCREChttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00543-1
mdprc 107 04 14 001Medtronic IncOccluded Extension Tubing in Refill Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126819
mdprc 070 05 14 000SIEMENSMAGNETOM Aerahttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00515-1
mdprc 069 05 14 000Hill Rom IncHill-Rom MC700 General Ward Bedhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00537-1
mdprc 068 05 14 000Biomet IncG7 Positioning Guide Rod & G7 Positioning Guide Posthttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00529-1
mdprc 067 05 14 000Baxter HealthcareMiniCap Extended Life PD Transfer Set with Twist Clamphttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00536-2
mdprc 064 11 13 002Welch Allyn Protocol IncWelch Allyn Propaq LT and Propaq 802 with Nellcor SpO2NCAR
mdprc 055 05 14 000ConMed CorporationConMed MacroLyte Premie Dispersive Electrodehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00522-1
mdprc 054 05 14 000Wright Medical Technology IncPATH Thread Cup Adaptorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00513-1
mdprc 053 05 14 000Thermo Fisher Scientific Microbiology Perth incMueller Hinton-HTM (culture media)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00454-1
mdprc 051 05 14 000Oxoid Div ThermoFisher Scientific Microbiology PerthOxoid Antimicrobial Susceptibility Testing Penicillin (P1) Discshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00506-1
mdprc 050 05 14 000Ortho-Clinical DiagnosticsVITROS 4600 Chemistry System, VITROS 5600 Integrated System and VITROS 5,1 FS Chemistry Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00502-1
mdprc 048 05 14 000FUJIFILM Medical SystemsSynapse Cardiovascular (CV) Client applicationhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00482-1
mdprc 087 02 14 002Siemens Healthcare Diagnostics ProductVersaCell connected to IMMULITE 2000/IMMULITE 2000 XPi analysersTGA, Swissmedic, BfArM
mdprc 031 05 14 000Stryker Endoscopy12-Instrument Sterilization Trayhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00480-1
mdprc 030 05 14 000Medtronic Navigation IncMedtronic Navigation Sterile Deviceshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00500-1
mdprc 026 05 14 000GE HealthcareCentricity PACS RA1000 Workstations.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00442-1
mdprc 004 05 14 002Leica BiosystemsBond Ready-To-Use Primary Antibody Thyroglobulin (1D4)RC-2014-RN-00476-1 & MHRA (2014/004/017/601/009)
mdprc 005 05 14 000GE HealthcareDiscovery 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 000SynthesCraniomaxillofacial (CMF) Distraction System, BC Distractor Body, end activated, with Universal Joint for CMF Distractorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00478-1
mdprc 002 05 14 000FUJIFILM Medical SystemsFUJIFILM 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 001Siemens Healthcare Diagnostics ProductAndrostenedione 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 001Covidien LLCPipeline Embolization Device and Alligator Retrieval Devicehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00415-1
mdprc 108 04 14 000Ortho-Clinical DiagnosticsenGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) v8.06http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00414-1
mdprc 106 04 14 000Life Technologies CorporationIVD,Dynabeads HLA (Human Leucocyte Antigen)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00416-1
mdprc 105 04 14 000Edwards LifesciencesFem-Flex II Arterial Cannulaehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00422-1
mdprc 104 04 14 000Covidien LtdEverCross .035" OTW PTA Catheter http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00431-1
mdprc 103 04 14 000Bayer Healthcare LLCMEDRAD Continuum Infusion Pumphttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00426-1
mdprc 102 04 14 000Baxter HealthcarePotassium 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 000Alcon LenSx, IncLenSx Laser Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00424-1
mdprc 169 02 14 001Johnson & Johnson Medical GmbHProceed Surgical Mesh.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00189-1
mdprc 058 04 14 000GE HealthcareVivid E9 Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00411-1
mdprc 093 03 14 001Baxter HealthcareHomeChoice PRO Automated Peritoneal Dialysis (PD) SystemTGA, MHRA
mdprc 049 04 14 000SIEMENSARTIS Zeegohttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00383-1
mdprc 048 04 14 000Philips Healthcare Gamma CamerasADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00405-1
mdprc 044 04 14 000GE HealthcareDiscovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM productshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00385-1
mdprc 042 04 14 000Solta Medical, Inc.Fraxel Dual 1550/1927 Laser Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00402-1
mdprc 094 03 14 001Philips HealthcarePhilips HeartStart Home and OnSite (HS1) Automated External Defibrillatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125837
mdprc 017 04 14 000Baxter HealthcareColleague Volumetric Infusion Pumpshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00384-1
mdprc 048 12 13 001Beckman CoulterIVDs, LH 750 and LH 780 Hematology Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01284-1
mdprc 134 03 14 000Synthes IncThreaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal couplinghttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00354-1
mdprc 133 03 14 000Device Technologies Australia Pty LtdCup Removal Instrumentshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00154-1
mdprc 028 03 14 001Philips HealthcarePhilips HeartStart FR3http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125857
mdprc 115 03 14 000ZOLL Medical CorpZoll X Series Defibrillators with systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00348-1
mdprc 168 02 14 001Integra LifeSciences ORTHOPAEDICHINTEGRA Standard and Revision tibial and talar componentshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00200-1
mdprc 101 03 14 001Draeger Medical Systems IncLatex Test Lungs and Latex Rebreathing Bagshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00332-1
mdprc 100 03 14 000Smiths MedicalHOTLINE Fluid Warming Setshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00344-1
mdprc 099 03 14 000Siemens Healthcare Diagnostics GmbHDimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE) Flex Reagent Cartridgehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00334-1
mdprc 098 03 14 000Unomedical IncUnomedical Feeding Tubeshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00278-1
mdprc 097 03 14 000Boston ScientificCAPIO Sutureshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00335-1
mdprc 096 03 14 000Integra LifeSciences LtdCUSA 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 000Zimmer incMetal-Backed Patella from Natural-Knee II Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00336-1
mdprc 092 03 14 000SIEMENSSymbia T and Symbia T2 Camera Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00340-1
mdprc 073 03 14 000Intelerad Medical Systems Inc.INTELEVIEWER, Versions 3.8.1 P355 and uphttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00292-1
mdprc 071 03 14 000Medtronic NeuromodulationBrain and Spinal Cord Stimulatorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00289-1
mdprc 070 03 14 000Medtronic NeuromodulationSpinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient Programmershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00288-1
mdprc 069 03 14 000bioMerieux IncFB Reagent, ZYM B Reagent, API Listeria and API NHhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00293-1
mdprc 032 03 14 001Thermo Fisher Scientific OyIndiko and Indiko Plus Chemistry Analysershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00212-1
mdprc 016 03 14 001Accumetrics IncVerifyNow Iib/IIIa 25 Test and VerifyNow Iib/IIIa 10 Testhttp://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 001Roche Diagnostics LtdElecsys HIV combi PT assayhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00030-1
mdprc 027 03 14 000CovidienHead Positioning Deviceshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00215-1
mdprc 026 03 14 000BrainLABExacTrac 6.0.3 Patient Positioning Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00269-1
mdprc 017 03 14 000Heartsine TechnologiesSamaritan PAD 500Phttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00243-1
mdprc 092 01 14 001Siemens Healthcare Diagnostics ProductOsteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00036-1
mdprc 105 02 14 001ThermoFisher Scientific Microbiology PerthCalibrator 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 000The Binding SiteSPAPLuS Analysers.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00098-1
mdprc 164 02 14 000Philips HealthcarePhilips HeartStart MRx Monitor/Defibrillatorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00188-1
mdprc 163 02 14 000Baxter HealthcareAquarius Regional Citrate Anticoagulation (RCA) Haemofiltration Devicehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00095-1
mdprc 143 02 14 000GE HealthcareNeuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00179-1
mdprc 141 02 14 000Siemens Healthcare DiagnosticsADVIA Centaur XP Immunoassay Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00181-1
mdprc 140 02 14 000Carl Zeiss Meditec IncOPMI 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 000Acumed LLCVolar Distal Radius (VDR) Proximal Targeting Guidehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00162-1
mdprc 107 02 14 000The Binding SiteThe Binding Site SPAPLuS analyserhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00150-1
mdprc 106 02 14 000LUTONIXLUTONIX 014 and 035 OTW Drug Coated PTA Dilatation Catheterhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00153-1
mdprc 104 02 14 000bioMerieux IncEtest 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 001BrainLABInstrument Star Unit ML (Calibration with ICM4)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124519
mdprc 084 02 14 000GE HealthcareInfinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00143-1
mdprc 050 02 14 000Siemens Medical SolutionsMRI-Stretcher non-magnetichttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00125-1
mdprc 049 02 14 000GE HealthcarePrecision 500D and Proteus XR/a with Wireless Digital Radiography Optionhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00121-1
mdprc 048 02 14 000GE HealthcareSolar 8000M and Solar 8000i Patient Monitor softwarehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00114-1
mdprc 012 02 14 001Covidien LLCPuritan Bennett 840 Ventilator and 700 Series (740 and 760) Ventilatorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00093-1
mdprc 136 12 13 001Becton Dickinson & Co. (BD)BD BACTED FX - Top Unit and Bottom Unithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125075
mdprc 027 02 14 000SIEMENSACUSON SC2000http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00076-1
mdprc 024 02 14 000Mckesson Medical Imaging GroupHorizon Medical Imaging (HMI) products softwarehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00101-1
mdprc 004 02 14 001SynthesIncHolding Forceps for SynReam Reaming Rod 2.5 mmhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00097-1
mdprc 103 01 14 001Baxter HealthcareVented Spike with Clearlinkhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00033-1
mdprc 104 01 14 000Schell MedicalManual Pulmonary Resuscitatorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00025-1
mdprc 102 01 14 000St. Jude Medical IncICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev.0http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00034-1
mdprc 094 01 14 000Carestream Health Inc Div Onex CorpKodak DirectView DR 7500 Systems.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00031-1
mdprc 093 01 14 000Philips Healthcare Gamma CamerasBrightView 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 001International Technidyne CorporationCitrate Activated Partial Thromboplastin Time (APTT) Cuvetteshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01364-1
mdprc 075 01 14 000Siemens Medical SolutionsMagnetom Spectra Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00023-1
mdprc 067 01 14 000Matrix Surgical Pty LtdMatrix Surgical Laparoscopic Spatula with cablehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00020-1
mdprc 046 01 14 000GE HealthcareVarious Innova Cardiovascular X-Ray Systems.http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00018-1
mdprc 045 01 14 000GE HealthcarePrecision 500D / Precision MPI / Precision RXI X-ray imaging systems equipped with LCD Video Monitorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00016-1
mdprc 088 11 13 001Ansell Healthcare Products LLCAnsell Sandel Weighted Safety Scalpelhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124491
mdprc 146 10 13 001Medtronic IncHYBRID Guide Wires, ATTAINhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01086-1
mdprc 027 01 14 000SIEMENSUltrasound imaging system, ACUSON SC2000http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00005-1
mdprc 026 01 14 000Smith & Nephew OrthopaedicJoint prosthesis, Knee, Femoral Implant, Journey BCS Knee Replacement Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00004-1
mdprc 025 01 14 000Siemens Healthcare Diagnostics ProductImmunoassay analyser, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00003-1
mdprc 174 12 13 000Stryker OrthopaedicsTrident Tritanium Acetabular Window Trials Casehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01356-1
mdprc 173 12 13 000Highland Metals Inc.SuperElastic NiTi Archwireshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01337-1
mdprc 171 12 13 000Siemens Healthcare Diagnostics ProductRAPIDLyte Arterial Blood Sampling Line Draw Syringeshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01310-1
mdprc 170 12 13 000Life HealthcareLaparascopic inserts with tube, 3.00mm http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01307-1
mdprc 169 12 13 000Philips HealthcareBrilliance iCT with Software Version 4.1.0.19260http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01333-1
mdprc 049 11 13 001Baxter Healthcare15L Cycler Drainage Baghttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01096-1
mdprc 156 11 13 001Smiths MedicalMedfusion 4000 Syringe Infusion Pump.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124427
mdprc 159 12 13 000Johnson & Johnson Medical GmbHEVOTECH Endoscope Cleaner and Reprocessor (ECR)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01344-1
mdprc 158 12 13 000GE HealthcareGiraffe Stand Alone, Giraffe Warmer Integrated, Panda Warmer Integrated, Panda Freestanding Warmer Integrated Resuscitation Systems with Blenders, Resuscitation System field upgrade kits with Blenderhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01334-1
mdprc 172 11 13 002Abbott Diabetes Care Div Abbott Laboratories IncFreeStyle Lite Blood Glucose Test Stripshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123972
mdprc 141 12 13 000Welch Allyn Protocol IncAcuity Central Monitoring Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01319-1
mdprc 138 12 13 000GE HealthcareMobile 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 000Ellex Medical Pty LtdKARMA Corneal Inlay http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01254-1
mdprc 129 12 13 000Medrad IncMedrad Veris MR Vital Signs Monitorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01312-1
mdprc 128 12 13 000Siemens Medical SolutionsScanning Systems, SOMATOM CT System http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01317-1
mdprc 111 12 13 000Integra NeuroSciencesCEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspiratorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01300-1
mdprc 103 12 13 000GE Healthcare X-Ray Imaging Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01299-1
mdprc 102 12 13 000Carestream Health Inc Div Onex CorpDRX Revolution Mobile X-Ray Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01269-1
mdprc 096 12 13 000Boucher & MuirViscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mLhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01262-1
mdprc 095 12 13 000Bio-Rad Laboratories IncHaemoglobin Testing System, D-10 Dual Program Reorder Packhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01258-1
mdprc 077 12 13 000GE HealthcareResuscitation Systems , Giraffe and Panda Resuscitation Systems with Blendershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01295-1
mdprc 076 12 13 000B Braun Medical IncSANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBINGhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01289-1
mdprc 075 12 13 000Elekta LimitedVolume Imaging System (XVI)http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01291-1
mdprc 074 12 13 000Elekta LimitedIntegrity Digital Linear Acceleratorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01290-1
mdprc 073 12 13 000Carestream Health Inc Div Onex CorpCarestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream Premium Wall Stand and Kodak DirectView DR 7500 System with Full FeaturedWall Standhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01285-1
mdprc 072 12 13 001Sorin GroupSorin Perfusion System - S5/C5 Heart Lung Machinehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01283-1
mdprc 071 12 13 000Siemens Healthcare Diagnostics GmbH(IVD), Dimension Vista Systems, Cyclosporine (CSA) Flex reagent cartridgehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01297-1
mdprc 056 12 13 000Ultimate Medical LtdTracheal tube http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00041-1
mdprc 052 12 13 000Smiths MedicalEpidural Minipack Systems, Anaesthesia Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01154-1
mdprc 049 12 13 000Hospira IncInfusion 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 000Ortho-Clinical DiagnosticsVITROS 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 000Elekta LimitedX-ray Volume Imaging System (XVI),http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01287-1
mdprc 171 11 13 001Sorin GroupREPLY and ESPRIT Pacemakershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01229-1
mdprc 118 11 13 001Boston ScientificVessix Generator Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01213-1
mdprc 023 12 13 000GE HealthcarePET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01265-1
mdprc 022 12 13 000GE HealthcarePatient Data Module (PDM) used with B850, B650, B450, Solar 8000i, MacLab / ComboLabhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01255-1
mdprc 021 12 13 000Leica Microsystems Inc.Leica M525 F50 Surgical Microscope with XY-Unithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01256-1
mdprc 019 12 13 000Elekta LimitedXiO versions 4.50 and higherhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01278-1
mdprc 018 12 13 000Ortho-Clinical DiagnosticsCalibration Diskette and Assay Data Disks used with VITROS chemistry instrumentshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01257-
mdprc 005 12 13 000Zimmer incProstheses, Joint, Knee , Prostheses, Joint, Hip , Nails, Bone , Pins, Bone , Plates, Bone , Orthopedic Internal Fixation Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01250-1
mdprc 004 12 13 000Zimmer incTrabecular Metal Reverse Shoulder Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01243-1
mdprc 002 12 13 000Ortho-Clinical DiagnosticsMicro Well Shuttle Weight used in VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01249-1
mdprc 001 12 13 000GE HealthcarePatient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLabhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01234-1
mdprc 159 11 13 000Ortho-Clinical DiagnosticsIVD, 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 000Boston Scientific LtdTWISTER PLUS Rotatable Retrieval Device 22mm and 26mmhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01241-1
mdprc 157 11 13 000Stryker InstrumentsModular Finishing Instrument Tray Assemblyhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01246-1
mdprc 115 11 13 001Medtronic Endovascular TherapiesIN.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 000FHC IncStar Drive Frame Adapters and Positionershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01134-1
mdprc 063 11 13 001Boston Scientific LtdUreteral Access Sheath Set used with Boston Scientific 13F/15F Navigator HDhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01141-1
mdprc 029 10 13 001Beckman Coulter IncIVD : 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 001Ortho-Clinical DiagnosticsVITROS Chemistry Products MicroSlideshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00773-1
mdprc 117 11 13 000Siemens Healthcare Diagnostics GmbHBFT 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 000Baxter HealthcareVented Spike Adaptershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00948-1
mdprc 051 10 13 001Carestream Health Carestream PACS Client Workstationhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01022-1
mdprc 111 11 13 000Siemens Healthcare Diagnostics GmbHADVIA 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 000StrykerStryker NV Excelsior, NV Neuroform 3EZ-3.0x15mm and 3EZ-3.5x15mm Microcathetershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01156-1
mdprc 062 11 13 002StrykerTeflon Tube T2 Humerus, Sterilehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01151-1
mdprc 089 11 13 000Life Technologies CorporationIVD : 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 000GE HealthcareCARESCAPE Monitor B850http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01136-1
mdprc 065 11 13 000Varian Medical SystemsLinear accelerator system. Clinac, Trilogy, Trilogy Tx, Novalis Tx and Unique accelerators, software versions 7.x, 8.x and 9.0http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01133-1
mdprc 061 11 13 000Philips Healthcare Gamma CamerasADAC ARGUS Gamma Camera Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01149-1
mdprc 051 11 13 000Hill RomClinActiv and ClinActiv Plus Therapy Surfacehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01108-1
mdprc 050 11 13 000FUJIFILM Medical SystemsX-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 000FenwalFenwal Transfer Pack 150ml with spike couplerhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2012-RN-01290-1
mdprc 157 10 13 001Siemens Healthcare Diagnostics GmbHX-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 001Alere San DiegoIVD : Panbio Barmah Forest Virus IgM ELISAhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01106-1
mdprc 015 11 13 000Philips HealthcareMDC PACShttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01110-1
mdprc 014 11 13 000Siemens Medical SolutionsE.cam and Symbia E systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01118-1
mdprc 013 11 13 000GE HealthcareCARESCAPE Monitor B850 and CARESCAPE Monitor B650http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01109-1
mdprc 010 11 13 000Baxter HealthcareHomechoice Pro APD Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01117-1
mdprc 008 11 13 000Abbott Point of CareCoagulation assay kit, i-STAT PT/INR cartridgehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01119-1
mdprc 147 10 13 001Philips HealthcareDiagnostic Ultrasound System, EPIQ 7http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01085-1
mdprc 067 10 13 001StrykerTPS MicroDriverhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01048-1
mdprc 003 11 13 000Synthes Inc8.5 mm Flexible Intramedullary Nailing System Reamer Headshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01102-1
mdprc 168 10 13 000Device Technologies Australia Pty LtdVygon Nutrisafe Syringe Feeding Pumpshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01065-1
mdprc 167 10 13 000Device Technologies Australia Pty LtdReliance Endoscope Processing System (EPS).http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01053-1
mdprc 166 10 13 000Ortho-Clinical DiagnosticsVITROS Chemistry Products Na+ Slides and Calibrator Kit 2http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01099-1
mdprc 145 10 13 000Vision-Sciences, Inc.Novacell Battery Charger supplied with the BLS-1000 Light Source sethttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01091-1
mdprc 134 10 13 000GE HealthcareBrivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01089-1
mdprc 132 10 13 000Applied Medical ResourcesInzii 12/15mm Retrieval Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01090-1
mdprc 131 10 13 000RaySearch Laboratories ABRayStationhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01103-1
mdprc 130 10 13 000Thermo Fisher Scientific Inc.CEDIA Tobramycin II Assayhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01097-1
mdprc 098 10 13 000Philips HealthcarePicture archiving and communication system , IntelliSpace PACS 4.4http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01072-1
mdprc 097 10 13 000Baxter HealthcareXenograft,TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI GUARDhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01036-1
mdprc 096 10 13 000Vygon UK LtdVygon Purple Nutrisafe Feeding Tube 10 FRhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01043-1
mdprc 095 10 13 000Med-Chem Surgical Pty LtdElectrosurgical electrode, PEB01H Diathermy Pencilhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01032-1
mdprc 094 10 13 001GE HealthcareVarious Nuclear Medicine Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01062-1
mdprc 070 10 13 000Philips HealthcareMonitoring Systems, Physiologic , Expression Information Portals Used with Expression MRI Patient Monitoring Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01052-1
mdprc 069 10 13 000bioMerieux IncIVD , 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 000Hospira IncSapphire 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 000GE HealthcareAvance, 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 000Medtel Pty LtdMagstim 90mm High Power Coilhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01014-1
mdprc 030 10 13 000Synthes IncPlate Medial Tibia 4 Hole Standard and Small Proximal Medial Tibia 4 Hole 112 mm Titanium Sterile, TomoFixhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01018-1
mdprc 028 10 13 000Beckman CoulterIVD : UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01021-1
mdprc 027 10 13 000bioMerieux IncIVD, TREPANOSTIKA TP Recombinant Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00174-1
mdprc 097 09 13 001BD BiosciencesBBL MGIT Mycobacteria Growth Indicator Tubehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00975-1
mdprc 018 10 13 000FIAB SpAFIAB Ultrasound Transmission and IPL Transparent Gelhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00165-1
mdprc 122 09 13 000Fluoron GmbHFluoron Gas Tamponadeshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00266-1
mdprc 121 09 13 000Beckman CoulterIVD : Beckman Coulter LH 750 & 780 Hematology Analysershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01019-1
mdprc 120 09 13 000Siemens Healthcare DiagnosticsDiagnostic blood gas analyser, RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01001-1
mdprc 119 09 13 000Philips HealthcareUltrasound imaging, EPIQ 7 Ultrasound systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01011-1
mdprc 111 09 13 000Stryker EndoscopyVision Mounting Arms Used with Video Cartshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00976-1
mdprc 110 09 13 000Kerr CorpNX3 Try-In Gel Syringe Refills, Bleachhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00983-1
mdprc 095 09 13 000BD BiosciencesIVD : BD HLA-B27 Kithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00249-1
mdprc 094 09 13 000Siemens Healthcare Diagnostics GmbHIVD : LOCI Cardiac Troponin I Calibratorhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00972-1
mdprc 093 09 13 000MedtronicAngioplasty balloon dilatation catheter , NC Sprinter RX Balloon Dilatation Catheterhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00973-1
mdprc 092 09 13 000Carestream Health Mobile X-ray System, DRX Revolution, DRX Mobile Retrofit & DRX Transportablehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00970-1
mdprc 089 07 13 002HemoCue A BGlucose analyser, laboratory, HemoCue Glucose 201 Microcuvettes, single packedhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00694-1
mdprc 066 09 13 001Maquet Cardiopulmonary AGheart-lung bypass system, CARDIOHELP-Ihttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00946-1
mdprc 081 09 13 000SIEMENSx-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 000Grifols AustraliaIVD : Grifols Australia AHG Cardshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00947-1
mdprc 079 09 13 000GE HealthcareAnaesthesia Machines, Engstrom Ventilator & Aespire View, Aisys and Avancehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00953-1
mdprc 078 09 13 000Covidien LtdArgyle Single Lumen Polyurethane Umbilical Vessel Catheterhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00971-1
mdprc 077 09 13 000Alere LTDIVD : 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 001Philips HealthcareBrilliance 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 000Roche Diagnostics LtdIVD, Cobas b 101 HbA1c Testhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00954-1
mdprc 065 09 13 000Howard Wright LimitedHoward Wright Limited Hospital Beds and Stretchershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00936-1
mdprc 064 09 13 000Biomet 3i IncDental Implants , Bellatek Zirconia Abutmentshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00939-1
mdprc 063 09 13 000Biomet 3i IncBiomet 3i Dental Implantshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00938-1
mdprc 062 09 13 000Leica Microsystems Inc.Leica Ceiling Mountshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00935-1
mdprc 053 09 13 000Philips HealthcareBrightView XCThttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00944-1
mdprc 052 09 13 000BD Diagnostic SystemsBD 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 000Siemens Healthcare DiagnosticsADVIA 1200, 1650, 1800 and 2400 Clinical Chemistry Systemshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00933-1
mdprc 046 09 13 000Seating Dynamics Pty LtdSmart Drive Wheelchair Power Assist Modelhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00914-1
mdprc 045 09 13 000Roche Diagnostics LtdIVD : COBAS INTEGRA 800http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00926-1
mdprc 031 09 13 001Smith & Nephew OrthopaedicGENESIS II PS Articular Insertshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00912-1
mdprc 030 09 13 000Siemens Healthcare Diagnostics ProductFree T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analysershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00915-1
mdprc 026 09 13 000GE HealthcareDASH, PDM and Tram modelshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00258-1
mdprc 011 09 13 000Hoya CorporationPENTAX Gas/Water Feeding Valvehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00909-1
mdprc 002 09 13 000Bio RadLiquichek ToRCH Plus IgM Control - Positivehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00355-1
mdprc 182 08 13 000Siemens Healthcare DiagnosticsIVD : Berichrom Heparinhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00904-1
mdprc 173 08 13 000Smith & Nephew OrthopaedicInternal fixation device, Sterile K-Wire and Steinmann Pin Productshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00897-1
mdprc 172 08 13 000Baxter HealthcareInfusion 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 000Alpine Medical Pty LtdSterile Chlorohexidine Gluconate/Alcohol Swabshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00887-1
mdprc 166 08 13 000Siemens Healthcare Diagnostics GmbHData Management System , EasyLinkhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00893-1
mdprc 165 08 13 000CoreMed Pty LtdEar ventilation tubes , Fluoroplastic shepard button, 1.15mm and Fluoroplastic collar button, 1.25mmhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00888-1
mdprc 164 08 13 000Philips Healthcare imaging system TF PET/CT, Ingenuityhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00891-1
mdprc 125 08 13 001MAQUET IncOperating room device management system , Secondary 19" Touchscreen - TEGRIS Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00851-1
mdprc 040 08 13 001Smith & Nephew Orthopaedicsynovial fluid supplementation substance, Durolane 3ml http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00779-1
mdprc 103 08 13 001Smith & Nephew incBio-Absorbable Suture Anchorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00844-1
mdprc 136 08 13 000Ortho-Clinical DiagnosticsCK-MB Calibrators, VITROS Immunodiagnostic Productshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00367-1
mdprc 135 08 13 000Proact Medical LTDAdult CO2 Sampling Oxygen Mask, OxyCaphttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00356-1
mdprc 133 08 13 000Oxoid LtdOxoid 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 000GE HealthcareAnesthesia Unit Vaporizers , Tec 6 and Tec 6 Plus Vaporizershttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00845-1
mdprc 066 08 13 001Leica Microsystems Inc. - LABBond Polymer Refine Red Detection Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00824-1
mdprc 107 08 13 0003M HealthcareCast Padding, 3M Scotchcast Wet or Dry Cast Paddinghttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00861-1
mdprc 106 08 13 000Megadyne Medical Products IncE-Z Clean, L-Wire Laparoscopic Electrode Split Stem, 45cmhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00854-1
mdprc 105 08 13 000Bio Rad(IVD), Liquichek Sedimentation Rate Control, Level 2http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00841-1
mdprc 104 08 13 000Philips HealthcareCT imaging, MX 16-Slicehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00849-1
mdprc 102 08 13 000Draeger Medical IncFabius Anaesthesia Machinehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00835-1
mdprc 101 08 13 000Smiths MedicalPortex Blue Line Disposable Inner Cannula, 7mmhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00828-1
mdprc 100 08 13 000GE HealthcareTemperature Probes , Model M1024229 9 Fr Disposable General Purpose Temperature Probeshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00807-1
mdprc 093 08 13 000Device Technologies Australia Pty LtdUltrasonic 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 000Hill Rom IncBeds, Electric, Hill-Rom VersaCare VC 755 Bedhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00331-1
mdprc 091 08 13 000A-dec IncA-dec 311 Chair and A-dec 361 Support Centrehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00380-1
mdprc 084 08 13 000Gerontic & General Products Pty LtdLifeCare P5 Premium Bedhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00448-1
mdprc 083 08 13 000Laerdal Pty LtdReceptal 1000 mL liner and canister, Laerdal Suction Unithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00440-1
mdprc 082 08 13 000Beckman Coulter IVD, automated , Access 2 Immunoassay System with Software Version 3.4http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00469-1
mdprc 192 07 13 001Nestle Healthcare NutritionCompat Nasogastric Feeding Tubehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00764-1
mdprc 184 07 13 001Philips HealthcareCT Scanner, MX8000 IDT 16 Slice CT Scannerhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00747-1
mdprc 065 08 13 000Philips HealthcareAllura Xper FD10 F and Allura FD10/10http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00813-1
mdprc 064 08 13 000HemoCue A BHemoCue Glucose 201 RT Microcuvettes http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00782-1
mdprc 063 08 13 000CSL BehringPhenocell 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 000Synthes IncBlackmax, 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 001Medtronic IncMullins Transseptal Catheter Introducer 7 French Sheathhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00715-1
mdprc 047 08 13 000AIMEDICS Pty LtdHypoMon Alarm Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00755-1
mdprc 046 08 13 000GE HealthcareViewPoint including OB Pro-Expert Reportinghttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00812-1
mdprc 045 08 13 000The Anspach Effort, Inc.Endoscopes, rigid, accessorieshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00530-1
mdprc 039 08 13 000Siemens Healthcare DiagnosticsADVIA Centaur Folate ReadyPackhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00778-1
mdprc 038 08 13 000Oxoid LtdOxoid Antimicrobial Susceptibility Testing Discshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00776-1
mdprc 036 08 13 000Medtronic Xomed IncMedtronic Xomed Instrument Trayshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00781-1
mdprc 035 08 13 000FUJIFILM Medical SystemsFujiFilm 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 000Edwards LifesciencesShunts, Pulmonary Artery, Anastaflo Intravascular Shuntshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00810-1
mdprc 032 08 13 000Cell Marque CorporationCell Marque CDX-2 (EPR2864Y*) antibody 7mlhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00776-1
mdprc 199 07 13 000Steris CorpUltra Concentrate Alkaline Detergent, 5L and 10L Prolysticahttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00570-1
mdprc 196 07 13 000SGM Biomedical IncorporatedBiological Indicators, EZTest steam and Smart-Read EZTest steamhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00589-1
mdprc 195 07 13 000SIEMENSBiograph mCT PET-CT Systems with VG40A Softwarehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00623-1
mdprc 194 07 13 000Siemens Healthcare DiagnosticsClinical chemistry analyser, Dimension Vista RF Flex Reagent Cartridgehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00750-1
mdprc 193 07 13 000Philips HealthcareComputed Tomography, Brilliance iCT and iCT SPhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00766-1
mdprc 190 07 13 000Livingstone International Pty LtdSterile Disposable Syringe 3mL - Luer Sliphttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00739-1
mdprc 189 07 13 000HemoCue A BHemoCue Urine Albumin Microcuvetteshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00753-1
mdprc 188 07 13 000Arjo Huntleigh - electric bedsContoura 380 and 480 Bedhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00762-1
mdprc 058 07 13 001Edwards LifesciencesRigid Suction Wandshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00675-1
mdprc 147 07 13 001BrainLABFrameless 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 000RaySearch Laboratories ABRadiation therapy treatment planning system, Raystationhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00734-1
mdprc 149 07 13 000Baxter HealthcareClearlink System Solution Sethttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00741-1
mdprc 148 07 13 000Atrium Medical CorporationPTFE Grafts, ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SSThttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00737-1
mdprc 146 07 13 000Medrad IncMedrad Hand Controller Sheathshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00619-1
mdprc 145 07 13 000Synthes IncLocking Screw Stardrive 2.4mm and 2.7mmhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00704-1
mdprc 114 07 13 000Pyramed Pty LtdNiti-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 000Ormco CorpMini 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 000B Braun Medical IncCementless Columbus Knee System http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00637-1
mdprc 105 07 13 000Medline Industries IncMedline 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 000CareFusionInfusion Pumps, Multitherapy, Alaris PC Unithttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00707-1
mdprc 088 07 13 000DiaSorin IncIVD: 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 000Siemens Healthcare DiagnosticsBuffers, Supplements, Reagesnts , ADVIA Centaur Homocysteine Diluenthttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00672-1
mdprc 059 07 13 001BrainLABRadiotherapy ,iPlan RT systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00687-1
mdprc 060 07 13 000AirSep CorporationOxygen Conserver device, AirSep Impulse Elitehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00462-1