| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 038 08 18 001 | Medtronic | BIS Vista and BIS View Monitoring Systems | NCMDR |
| mdprc 012 07 19 001 | Varian Medical Systems | Stainless Steel Interstitial Needles, 17 Gauge | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01003-1 |
| mdprc 008 03 19 001 | Biomet 3i Inc. | 3.4mm Certain BellaTek Abutment, ILDAT3 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171233 |
| mdprc 089 05 19 001 | Apollo Endosurgery Inc. | Orbera Intragastric Balloon System and BIB Intragastric Balloon System | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00675-1 |
| mdprc 009 08 19 000 | SIEMENS | MAMMOMAT Revelation VC10 with Biopsy Option | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01129-1 |
| mdprc 008 08 19 000 | Mesa Laboratories, Inc. | EZTest H202 Biological Indicators | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01128-1 |
| mdprc 007 08 19 000 | Cincinnati Sub-Zero Products Inc. | Norm-O-Temp Hyperthermia System, MICRO-TEMP LT System, Blanketrol II Hyper-Hypothermia System, Blanketrol III Hyper-Hypothermia System and CoolBlue Hyper-Hypothermia System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01127-1 |
| mdprc 006 08 19 000 | Allergan services international Limited | Textured Breast Implants and Tissue Expanders | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01116-1 |
| mdprc 115 07 19 000 | Henry Schein, Inc. | KaVo RONDOflex Powder 27µm 1000g to be used with the KaVo RONDOFLEX plus 360 air abrasion system | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01123-1 |
| mdprc 105 07 19 000 | Terumo BCT Inc | Spectra Optia Apheresis System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01111-1 |
| mdprc 104 07 19 000 | SIEMENS | SOMATOM Definition Edge , SOMATOM Definition AS, SOMATOM Definition Flash, with syngo | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01083-1 |
| mdprc 103 07 19 000 | SIEMENS | Biograph mCT and mCT Flow systems running PETsyngo VG70A | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01114-1 |
| mdprc 102 07 19 000 | Medicrea International. | PEEK Cervical Cages and PEEK Lumbar Cages | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01105-1 |
| mdprc 101 07 19 000 | Cooper Surgical, Inc. | TRANSWARMER Warming Infant Transport Mattresses. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01106-1 |
| mdprc 097 07 19 000 | SPIGGLE & THEIS Medizintechnik | Panetti ENT endoscopic ear instruments | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01102-1 |
| mdprc 096 07 19 000 | Radiometer America Inc | Radiometer ABL90FLEX blood gas analyser and Radiometer AQT90FLEX immunoassay analyser | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01093-1 |
| mdprc 077 07 19 000 | GE Healthcare | Fluorostar 7900 System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01085-1 |
| mdprc 076 07 19 000 | HEIDELBERG ENGINEERING GmbH | HEYEX 2 image management components of SPECTRALIS PC Software | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01065-1 |
| mdprc 075 07 19 000 | Phadia Ltd | ImmunoCAP Tryptase Control | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01091-1 |
| mdprc 074 07 19 000 | QIAGEN Ltd | QIAsymphony SP instrument (Software 5.0.3) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01096-1 |
| mdprc 031 03 19 001 | BioFire Diagnostics Inc. | FilmArray Gastrointestinal (GI) Panel. | NCMDR |
| mdprc 064 07 19 000 | Getinge | GETINGE Steam Steriliser | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01071-1 |
| mdprc 043 07 19 000 | Phadia Ltd | Phadia 1000 instrument | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01055-1 |
| mdprc 042 07 19 000 | Morcher GmbH | Morcher Capsular Tension Rings Type 13 Right, Type 13A Right and Type 13B Right | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00995-1 |
| mdprc 041 07 19 000 | BD Biosciences | BD Connecta Plus3 White (3 way stopcock) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01049-1 |
| mdprc 038 07 19 000 | GE Healthcare | MAC VU360 systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01054-1 |
| mdprc 026 07 19 000 | Nuvasive Specialized Orthopaedics Inc. | MAGEC System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01014-1 |
| mdprc 025 07 19 000 | Cyclomedica Australia Pty Ltd | TechnegasPlus Generator | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01023-1 |
| mdprc 058 05 19 001 | Siemens Healthcare Diagnostics | Creatine Kinase on the Atellica Chemistry platform | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173277 |
| mdprc 011 07 19 000 | Beckman Coulter | AQUIOS IMMUNO-TROL Low Cells | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01033-1 |
| mdprc 037 05 19 001 | Baxter Healthcare | Prismaflex devices with software version 8.10 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00691-1 |
| mdprc 092 06 19 000 | Medical Innovation Developpement SAS | MID-Tube, Orogastric calibration Tube | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00985-1 |
| mdprc 089 06 19 000 | Arjo Huntleigh | Tenor Passive Floor Lift | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00978-1 |
| mdprc 018 06 19 001 | Teleflex Medical | Sheridan Endotracheal Tubes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173225 |
| mdprc 069 06 19 000 | RSR Ltd | ACHRAb RIA kits. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00918-1 |
| mdprc 068 06 19 000 | Zimmer | Comprehensive Reverse Shoulder Instrument Cases | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00922-1 |
| mdprc 050 06 19 001 | Becton Dickinson & Co. (BD) | Microtainer Tubes | Swissmedic |
| mdprc 053 06 19 000 | Terumo BCT Inc | Spectra Optia Apheresis System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00878-1 |
| mdprc 052 06 19 000 | Randox Laboratories Ltd. | Assayed Bovine Multi-Sera - Level 1 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00917-1 |
| mdprc 051 06 19 000 | Magic Mobility | Magic mobility wheelchair - Mobility Handles | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00907-1 |
| mdprc 049 06 19 000 | Beckman Coulter | SYNCHRON Systems Phosphorus Reagent (PHOSm) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00916-1 |
| mdprc 083 04 19 001 | Accuray Inc. | CyberKnife M6 and CyberKnife VSI Secondary Collimation Subsystem | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172287 |
| mdprc 017 06 19 000 | QIAGEN Ltd | Filter-Tips, 1500 µl (1024) used with QIAsymphony SP/AS Instruments | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00857-1 |
| mdprc 016 06 19 000 | Philips Healthcare | Philips Incisive Computed Tomography x-ray system | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00847-1 |
| mdprc 015 06 19 000 | CODAN Medizinische Geraete GmbH & Co KG | Codan Extension Set | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00813-1 |
| mdprc 014 06 19 000 | Nanjing Mindray Bio-Medical Electronics Co., Ltd. | HyLED Surgical Light Series 7, 8 and 9 | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00764-1 |
| mdprc 013 06 19 000 | Pride Mobility Products Ltd | J623 Power Wheel Chairs ("Jazzy 623") fitted with Dynamic Controls Shark Power Module | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00797-1 |
| mdprc 012 06 19 000 | Beckman Coulter UK Ltd | UniCel DxH 800/600/900 Coulter Cellular Analysis System. | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00808-1 |
| mdprc 056 08 18 001 | Beckman Coulter Inc.. | UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171361 |
| mdprc 114 05 19 000 | Aidacare Pty Ltd | Tilt & Recline Shower Commode: Aspire, 46cm and 53cm | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00736-1 |
| mdprc 113 05 19 000 | GE Healthcare | LVivo EF app on Vscan Extend | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00765-1 |
| mdprc 112 05 19 000 | Nidek Co. Ltd. | CEM-530 Specular Microscope | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00789-1 |
| mdprc 111 05 19 000 | SIEMENS | MAGNETOM Vida and Sola with syngo MR XA11 software | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00773-1 |
| mdprc 113 04 19 001 | Integra LifeSciences | LimiTorr Volume Limiting External CSF Drainage and Monitoring Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172225 |
| mdprc 092 05 19 000 | Change Healthcare | McKesson Cardiology Hemo Systems | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00745-1 |
| mdprc 091 05 19 000 | Medicina | ENFit NGP and Ryles Nasogastric Feeding Tubes | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00754-1 |
| mdprc 090 05 19 000 | Beckman Coulter UK Ltd | Power Express Sample Processing System | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00756-1 |
| mdprc 081 05 19 000 | Ivor Shaw Limited As Peninne Healthcare | Various Gastric Tubes and Catheters | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00746-1 |
| mdprc 059 05 19 000 | Siemens Healthcare Diagnostics | Creatine Kinase on the ADVIA Chemistry platform | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00732-1 |
| mdprc 057 05 19 000 | Medtronic | O-Arm 1000 Imaging Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00728-1 |
| mdprc 115 04 19 001 | MacoPharma | ACDA Anticoagulant Solution | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00633-1 |
| mdprc 051 05 19 000 | Medtronic | Medtronic HeartWare Monitor AC Adapter | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00703-1 |
| mdprc 059 08 18 001 | Air Liquide Medical Systems | Matrx Digital MDM Mixer | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00663-1 |
| mdprc 038 05 19 000 | MAKO Surgical | 2.7 Degree Angled Sagittal Saw attachment and 2.7 Degree Straight Sagittal Saw attachment | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00680-1 |
| mdprc 078 04 19 001 | Boston Scientific | Auriga 30 Laser System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00565-1 |
| mdprc 061 04 19 001 | Arc Laser GmbH | Wolf 445nm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00550-1 |
| mdprc 028 05 19 000 | Edwards Lifesciences | lntroFlex lntroducers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00683-1 |
| mdprc 027 05 19 000 | C R Bard Inc. | EnCor Breast Biopsy Probes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00664-1 |
| mdprc 026 05 19 000 | Beckman Coulter | IMMAGE Immunochemistry Systems Immunoglobulin M (IGM) Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00688-1 |
| mdprc 021 05 19 000 | Sysmex Corporation | Sysmex SP-50 slidemaker-stainer | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00672-1 |
| mdprc 020 05 19 000 | SIEMENS | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.All, SOMATOM go.Top | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00667-1 |
| mdprc 019 05 19 000 | Covidien | Monoject Standard Hypodermic Needles | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00671-1 |
| mdprc 009 05 19 000 | Zimmer | Alvarado Knee Holder Base Plate Assemblies and Foot Pieces and Alvarado II Base Plates and Foot Pieces | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00660-1 |
| mdprc 146 04 19 000 | SIEMENS | Biograph Vision 600 and Biograph Vision 600 Edge (with VG75A or B software and the PATLAK reconstruction license) | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00650-1 |
| mdprc 111 04 19 001 | Carestream Health | Carestream Onsight 3D Extremity System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171699 |
| mdprc 084 04 19 001 | Cook Medical | Pericardiocentesis Catheter Set | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00568-1 |
| mdprc 062 04 19 001 | Beaver Visitec International Ltd | Visiwipe Instrument Wipe 73 x 73mm | BfArM |
| mdprc 116 04 19 000 | Teleflex Medical | Rüsch Lasertubes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00606-1 |
| mdprc 114 04 19 000 | Istanbul Medikal Ltd | Medwarm neonate and Medwarm neonate with Skin temp port and probe | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00643-1 |
| mdprc 112 04 19 000 | DiaSorin Inc. | Liaison XL and Liaison XL LAS with POM Stirrer Bar M | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00579-1 |
| mdprc 097 04 19 000 | Stryker | Berchtold CHROMOPHARE F 528 and F 628 Surgical Light System Light Head Covers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00575-1 |
| mdprc 086 04 19 000 | Oxoid Ltd | OXOID MICE Strip MA0122 – Ceftriaxone32 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00573-1 |
| mdprc 085 04 19 000 | Direct Healthcare Services Ltd | Mercury Advance V1 Control Unit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00563-1 |
| mdprc 082 04 19 000 | Abbott | TactiSys Quartz Equipment operating | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00571-1 |
| mdprc 079 04 19 000 | Cincinnati Sub-Zero Products Inc. | CSZ Haemotherm 400CE System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00565-1 |
| mdprc 077 04 19 000 | Baxter Healthcare | Microbore Y-Type Extension Set and Catheter Extension Set with Clearlink | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00567-1 |
| mdprc 087 02 19 001 | Olympus | Olympus Duodenovideoscope | NCMDR |
| mdprc 052 04 19 000 | Delfi Medical Innovations Inc. | VariFit Sterile Single Use Adult Thigh Cuffs, Single Port, Single Bladder | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00548-1 |
| mdprc 018 04 19 000 | Welch Allyn | TM55 Stress Testing Treadmills | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00484-1 |
| mdprc 099 03 19 000 | Medtronic SA | Drill Mini-Trephination 2.0mm | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00503-1 |
| mdprc 098 03 19 000 | Edwards Lifesciences | Miller and Fogarty Atrioseptostomy Catheters | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00499-1 |
| mdprc 087 03 19 000 | Biomet Spain Orthopaedics SL | Polished Finned 1 Piece Tibial Tray 71mm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00451-1 |
| mdprc 077 03 19 000 | Topcon Corporation | IMAGEnet 6 Ophthalmic Data System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00440-1 |
| mdprc 069 03 19 000 | Alba Bioscience | ALBAclone Anti-Leb Reagents | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00248-1 |
| mdprc 068 03 19 000 | Edwards Lifesciences | VAMP Optima Blood Sampling System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00433-1 |
| mdprc 067 03 19 000 | Medtronic | A610 DBS Clinic |