| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| 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 115 04 19 000 | MacoPharma | ACDA Anticoagulant Solution | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00633-1 |
| 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 113 04 19 000 | Integra LifeSciences | LimiTorr Volume Limiting External CSF Drainage and Monitoring Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00608-1 |
| 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 111 04 19 000 | Carestream Health | Carestream Onsight 3D Extremity System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00628-1 |
| 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 084 04 19 000 | Cook Medical | Pericardiocentesis Catheter Set | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00568-1 |
| mdprc 083 04 19 000 | Accuray Inc. | CyberKnife M6 and CyberKnife VSI Secondary Collimation Subsystem | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00576-1 |
| 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 078 04 19 000 | Boston Scientific | Auriga 30 Laser 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 061 04 19 000 | Arc Laser GmbH | Wolf 445nm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00550-1 |
| 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 Clinician Programmer Application | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00428-1 |
| mdprc 065 03 19 000 | Draeger Medical Systems Inc. | Infinity Acute Care System (IACS) and Infinity M540 Stand Alone Monitor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00405-1 |
| mdprc 080 10 17 002 | Radiometer | Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00374-1 |
| mdprc 032 03 19 000 | bioMerieux Inc. | ChromID CPS/Horse Blood Agar | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00375-1 |
| mdprc 031 03 19 000 | BioFire Diagnostics Inc. | FilmArray Gastrointestinal (GI) Panel. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00379-1 |
| mdprc 030 03 19 000 | Biocomposites Ltd | Genex Putty 5cc | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00380-1 |
| mdprc 017 03 19 000 | Phadia AB | ImmunoCAP ISAC sIgE 112 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00343-1 |
| mdprc 016 03 19 000 | Medtronic | Pulmonary Vein Ablation Catheter GOLD (PVAC GOLD) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00338-1 |
| mdprc 115 02 19 001 | Maquet Cardiopulmonary | Maquet Cardiopulmonary Pre-Bypass Filters used for Customised Tubing Packs | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00292-1 |
| mdprc 008 03 19 000 | Biomet 3i Inc. | 3.4mm Certain BellaTek Abutment, ILDAT3 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00349-1 |
| mdprc 007 03 19 000 | Varian Medical Systems | Velocity Advanced Imaging [AI], Velocity Advanced Imaging Solutions [AIS] or VelocityGRID | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00142-1 |
| mdprc 049 10 18 001 | Baxter Healthcare | EXACTAMIX Empty EVA Bags | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00291-1 |
| mdprc 091 02 19 000 | Ardo medical AG | Ardo Sterile Tulips Nipple Shields, Medium and Large | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00259-1 |
| mdprc 027 12 18 001 | Shimadzu Medical Systems. | Digital Angiography System Trinias | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170548 |
| mdprc 088 02 19 000 | SIEMENS | Multiple SOMATOM CT Scanners - syngo CT VB10A with Option Dual Spiral Dual Energy | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00262-1 |
| mdprc 086 02 19 000 | Medrobotics Corporation | Obturator, short cone 7" and long cone 10" (an accessory to the Flex Rectoscope) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00261-1 |
| mdprc 084 02 19 000 | Beckman Coulter | Access Thyroglobulin Antibody II Reagents | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00238-1 |
| mdprc 077 02 19 000 | Varian Medical Systems | TrueBeam Radiotherapy System with Visual Coaching Device or EDGE or VitalBeam | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00147-1 |
| mdprc 076 02 19 000 | Stryker | Xia 3 Degen Tray and French Bender instrument | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00206-1 |
| mdprc 075 02 19 000 | Shimadzu Medical Systems. | Mobile X-Ray System MobileDaRt Evolution Handle | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00205-1 |
| mdprc 074 02 19 000 | Clearstream Technologies Ltd | Bard Lifestream Balloon Expandable Vascular Covered Stent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00175-1 |
| mdprc 069 01 19 002 | Medtronic | Adapta Dual Chamber Pacemakers | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170377 |
| mdprc 060 02 19 000 | Varian Medical Systems | ARIA OIS for Radiation Oncology | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00169-1 |
| mdprc 059 02 19 000 | Randox Laboratories | Various Immunoassay Controls used with Siemens Immulite 2000 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00179-1 |
| mdprc 058 02 19 000 | Medrad Inc. | Radimetrics CDM Software | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00204-1 |
| mdprc 057 02 19 000 | GE Healthcare | Panda iRes Warmer with ResusView Heart Rate Feature | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00196-1 |
| mdprc 007 02 19 001 | Diagnostica Stago | STA – VWF:RCo reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00119-1 |
| mdprc 033 02 19 000 | FUJIFILM SonoSite, Inc | Sonosite L25 Needle Guide Bracket | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00034-1 |
| mdprc 032 02 19 000 | Ultradent Products, Inc. | UltraTemp & UltraTemp REZ | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00120-1 |
| mdprc 027 02 19 000 | Schulte-Elektronik | SISS BABYCONTROL Respiration Monitors | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00055-1 |
| mdprc 026 02 19 000 | Varian Medical Systems | VariSource HDR and GammaMed | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00140-1 |
| mdprc 025 02 19 000 | Edwards Lifesciences | Commander Delivery Systems. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00136-1 |
| mdprc 024 02 19 000 | Varian Medical Systems | ARIA Radiation Therapy Management | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00146-1 |
| mdprc 012 02 19 000 | Applied Medical Resources | 5x75mm Kii Fios Advanced Fixation Access System , | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00116-1 |
| mdprc 101 11 18 002 | Medtronic | Suction/Anticoagulation Assembly Lines | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169578 |
| mdprc 069 01 18 002 | Beckman Coulter | FC 500 Series Flow Cytometers | NCMDR |
| mdprc 130 10 18 001 | GE Healthcare | CARESCAPE R860 Inspiratory Safety Guard | NCMDR |
| mdprc 074 01 19 001 | bioMerieux Inc. | VITEK 2 - Card Pouch Integrity | NCMDR |
| mdprc 079 01 19 000 | Arthrex, Inc | BURR OVAL 12 FLUTE 5.5MM X 13CM , | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00101-1 |
| mdprc 076 01 19 000 | Shaoxing Fuqing Medical Products Co Ltd | Electronic Thermometer supplied in Tiny Tots First | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00085-1 |
| mdprc 075 01 19 000 | Edwards Lifesciences | Edwards Lifesciences IntraClude Intra-aortic Occlusion Device | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00086-1 |
| mdprc 056 01 19 001 | Medtronic | Programmer Software Update Supporting the Micra Transcatheter Pacing System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00079-1 |
| mdprc 055 01 19 000 | Cook Inc. | UNIVERSA Soft & Firm Ureteral Stent Sets, PTFE Wire Guide, Percutaneous Entry Set & Bander Ureteral Diversion Open-End Stent Set | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00068-1 |
| mdprc 013 01 19 001 | Immucor | Panocell-16 Kit | NCMDR |
| mdprc 014 01 19 000 | Limacorporate S.p.a. | Revision femoral neck H60mm lateralised + Screw | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00001-1 |
| mdprc 135 12 18 000 | Agilent Technologies, Inc. | Autostainer Slide Racks | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01606-1 |
| mdprc 133 12 18 000 | Getinge Disinfection AB | GETINGE XS32 Flat Screen Holder | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01602-1 |
| mdprc 046 05 17 001 | Natus Medical Inc. | neoBLUE blanket LED Phototherapy Systems , | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00043-1 |
| mdprc 106 12 18 000 | Olympus Winter & IBE GmbH | Various Olympus Grasping Forceps and Biopsy Forceps | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01556-1 |
| mdprc 104 12 18 000 | Medrad Inc. | Bayer Overhead Counterpoise mounting system | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01587-1 |
| mdprc 091 12 18 000 | Thermo Fisher Scientific Inc. | PP2001 HBA Agar Plates | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01562-1 |
| mdprc 090 12 18 000 | Stryker | Stryker Visum II LED Surgical Lighting system - EDS (Equipment Delivery System) Light Suspensions, Central Axis | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01555-1 |
| mdprc 089 12 18 000 | Stryker Communications | Stryker Visum II LED Surgical Lighting system - EDS (Equipment Delivery System) Light Suspensions, Central Axis | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01555-1 |
| mdprc 060 08 18 001 | MAKO Surgical Corp | Mako Vizadiscs and Vizadisc Hip Tracking Kit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01554-1 |
| mdprc 088 12 18 000 | Beckman Coulter | UniCel DxI 600 & 800 Access Immunoassay Systems & UniCel DxC 660i, 680i, 860i, 880i Synchron Access Clinical Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01564-1 |
| mdprc 087 12 18 000 | Amplitude | Anatomic Tibial Base Plate for fixed bearing insert cemented, Size 4 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01545-1 |
| mdprc 076 12 18 000 | SIEMENS | Biograph Horizon | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01547-1 |
| mdprc 075 12 18 000 | STEELCO | Steelco DS1000 washers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01540-1 |
| mdprc 074 12 18 000 | Rayner Intraocular Lenses Limited | RayOne Trifocal RAO603F + 10.5 D ADD 3.5 Intraocular Lens | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01538-1 |
| mdprc 073 12 18 000 | Novos Medical Systems Industry Trade Import and Export Ltd Co | Bililed Maxi+ Phototherapy Unit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01464-1 |
| mdprc 072 12 18 000 | DePuy | CORAIL Female Broaches (Size 9-20) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01495-1 |
| mdprc 071 12 18 000 | Becton, Dickinson And Company | BD Burette Sets | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01537-1 |
| mdprc 070 12 18 000 | B Braun Medical Inc. | Celsite Safety SST601F 6.5F SI - Access Ports | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01543-1 |
| mdprc 095 08 18 001 | Olympus | Olympus Bronchofiberscopes, Bronchovideoscopes, Bronchofibervideoscopes, Ultrasonic Bronchofibervideoscopes, Rhino-laryngo Videoscopes and Airway Mobilescopes | NCMDR |
| mdprc 059 12 18 000 | Microgenics Corp. | MAS Alcohol/Ammonia Control | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01530-1 |
| mdprc 002 12 18 002 | Medtronic | Medtronic HeartWare HVAD System Battery Charger | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169057 |
| mdprc 028 12 18 000 | Cis Bio International | Cisbio - Chromogranin A (CGA-ELISA) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01522-1 |
| mdprc 026 12 18 000 | Synovis Micro Companies Alliance Inc. | Synovis GEM4183C Coupler Forceps | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01519-1 |
| mdprc 018 12 18 000 | Hologic Inc. | I-View Contrast Enhanced Digital Mammography | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01515-1 |
| mdprc 017 12 18 000 | MED-EL Elektro-Medizinische Geraete GmbH | Sonata ti100 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01511-1 |
| mdprc 016 12 18 000 | SIEMENS | Syngo.plaza version VB30A_HF01 and previous software versions | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01509-1 |
| mdprc 015 12 18 000 | Stryker Neurovascular | Balloon Guide Catheters 9F | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01500-1 |
| mdprc 014 12 18 000 | Intuitive Surgical Inc. | da Vinci Xi Surgical System Arm Sensor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01501-1 |
| mdprc 003 12 18 000 | Optics Medical | Raindrop Near Vision Inlays | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01465-1 |
| mdprc 001 12 18 000 | Medicina | Medicina CG Nasogastric Tubes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01482-1 |
| mdprc 102 11 18 000 | RaySearch Laboratories | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7, and RayStation 8A | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01468-1 |
| mdprc 073 11 18 000 | Eurotrol B.V | HemoTrol Hemoglobin Controls | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01436-1 |
| mdprc 072 11 18 000 | GE Healthcare | Revolution CT Systems with SmartStep Option | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01452-1 |
| mdprc 071 11 18 000 | House With No Steps | FG107 Intravitreal Procedure Pack #1 and FG110 Intravitreal Procedure Pack #2A | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01442-1 |
| mdprc 070 11 18 000 | Misonix, Inc. | BoneScalpel and SonaStar FS1000 Ultrasonic Surgical Systems | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01444-1 |
| mdprc 055 11 18 000 | Diagnostica Stago | STACLOT LA (REF. 00600). | NCMDR |
| mdprc 038 11 18 000 | Carestream Health | Kodak DirectView DR 7500 System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01434-1 |
| mdprc 037 11 18 000 | Cambridge Nutritional Sciences Ltd | FoodPrint Microarray 200+ Food IgG. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01431-1 |
| mdprc 036 11 18 000 | BioArray Solutions Ltd. | HEA Precise Type Beadchip Kit and RHD Beadchip Kit, CE. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01435-1 |
| mdprc 017 11 18 000 | Argon Medical Devices | 4-Way Stopcock w/MLL, Adapter DBL Male and Female LL | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01423-1 |
| mdprc 005 11 18 000 | Carl Zeiss | Plex Elite 9000 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01414-1 |
| mdprc 152 10 18 000 | BioArray Solutions Ltd. | RHD BeadChip Kit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01399-1 |
| mdprc 132 10 18 000 | IRIS Diagnostics | iChemVELOCITY Urine Chemistry strips | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01395-1 |
| mdprc 131 10 18 000 | bioMerieux Inc. | NUCLISENS Lysis Buffer. An in vitro diagnostic medical device (IVD). | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01392-1 |
| mdprc 117 10 18 000 | Demeditec Diagnostics GmbH | Reverse T3 RIA | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01390-1 |
| mdprc 116 10 18 000 | Siemens Healthcare | Biograph mMR with software version syngo E11P when using BodyCOMPASS | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01388-1 |
| mdprc 112 10 18 000 | ICU Medical, Inc. | Lifeshield Primary Plum Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Tubing, Secure Lock 272 cm / 23 mL | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01375-1 |
| mdprc 111 10 18 000 | Paragon 28, Inc. | TITAN 3-D Wedge, Evans, Large, 10mm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01380-1 |
| mdprc 088 10 18 000 | LeMaitre Vascular | Pruitt F3-S Polyurethane Outlying Carotid Shunt | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01352-1 |
| mdprc 087 10 18 000 | Enterix Pty Ltd | ColoVantage Home-Faecal Immunochemical Test Kits. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01128-1 |
| mdprc 063 08 18 001 | Orthosensor Inc. | VERASENSE ZBH-PSNCREF311-R CR E-F/3-11 Right. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01135-1 |
| mdprc 048 10 18 000 | Belmont Instrument Corp | Buddy Disposable Sets | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01327-1 |
| mdprc 047 10 18 000 | Datascope Corp | CARDIOSAVE Intra-Aortic Balloon Pumps | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01317-1 |
| mdprc 046 10 18 000 | GE Healthcare | LOGIQ E10 ultrasound systems (when used with TEE probes) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01304-1 |
| mdprc 045 10 18 000 | Integra LifeSciences | CUSA Excel (Excel+) Ultrasonic Surgical Aspirator System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01324-1 |
| mdprc 044 10 18 000 | K2M Inc. | YUKON OCT Spinal System Polyaxial Screw Size 3.5 x 34mm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01326-1 |
| mdprc 043 10 18 000 | RaySearch Laboratories | RayStation and RayPlan | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01322-1 |
| mdprc 042 10 18 000 | Siemens Healthcare Diagnostics | Dimension Integrated Chemistry Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01328-1 |
| mdprc 041 10 18 000 | Siemens Healthcare Diagnostics | RAPIDPoint 500 Blood Gas Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01330-1 |
| mdprc 040 10 18 000 | SIEMENS | Biograph mCT and Biograph Horizon Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01329-1 |
| mdprc 018 05 17 001 | Abbott Medical Optics Inc. | Vitrectomy Cutter | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01301-1 |
| mdprc 031 10 18 000 | Medtronic | O-arm O2 Imaging Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01313-1 |
| mdprc 030 10 18 000 | TiSport | X-Short anti-tip tubes on certain TiLite manual wheelchairs | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01302-1 |
| mdprc 109 08 18 001 | Bio Rad | Pastorex Meningitis - reagent R4 (Streptococcus pneumoniae latex - green cap bottle). | Swissmedic Update |
| mdprc 088 09 18 000 | Abbott Laboratories | ARCHITECT ICT Modules | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01256-1 |
| mdprc 087 09 18 000 | Baxter Healthcare | AK 98 Hemodialysis Devices | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01233-1 |
| mdprc 086 09 18 000 | Leica | BOND Slide Labeller Zebra Printer Power Supply Unit (PSU) for use with BOND-lll and BOND-MAX instruments. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01254-1 |
| mdprc 085 09 18 000 | Samsung Electronics | Samsung Digital X-Ray System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00982-1 |
| mdprc 084 09 18 000 | Siemens Healthcare Diagnostics | ADVIA Chemistry Creatine Kinase (CK_L) System Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01271-1 |
| mdprc 081 09 18 000 | Alcon Laboratories Inc. | CyPass Micro-Stents | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01228-1 |
| mdprc 080 09 18 000 | Bio Rad. | VIROTROL HIV-1 Ag | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01255-1 |
| mdprc 079 09 18 000 | Bio-Rad Laboratories | D-100 Haemoglobin Testing System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01239-1 |
| mdprc 104 08 18 001 | Siemens Healthcare Diagnostics | Aptio Automation and StreamLAB Automation. | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01181-1 |
| mdprc 110 08 18 000 | AGFA Corp. | DX-D 600 Digital Radiography Systems | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01140-1 |
| mdprc 108 08 18 000 | Cepheid | Xpert Xpress Flu/RSV assay | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01155-1 |
| mdprc 107 08 18 000 | CERNER | Cerner Dosage Calculator used via PowerOrders or Pharmacy Medication Manager | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01060-1 |
| mdprc 106 08 18 000 | Evolutis | Broach Handles for rasp used in orthopaedic surgery | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01127-1 |
| mdprc 105 08 18 000 | Permobil | M300 PS, C300 PS, C350 PS, C500 PS, (PS Seating only) | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01143-1 |
| mdprc 103 08 18 000 | Smiths Medical | Jelco ViaValve safety I.V. catheter | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01206-1 |
| mdprc 102 08 18 000 | Stryker | Hoffmann Limb Reconstruction Frame (LRF) System Hexapod Struts | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01203-1 |
| mdprc 101 08 18 000 | Therakos Inc. | Therakos Cellex Photopheresis System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01156-1 |
| mdprc 100 08 18 000 | TransMedics | Organ Care System (OCS) Heart system - OCS Heart Console | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01113-1 |
| mdprc 099 08 18 000 | Vision RT | AlignRT Plus/OSMS system | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01166-1 |
| mdprc 096 08 18 000 | Medtronic | Tools Database v1.288 CD | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01137-1 |
| mdprc 064 08 18 000 | SPATZ FGIA, INC.. | Spatz3 Adjustable Gastric Balloon System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01039-1 |
| mdprc 062 08 18 000 | Medtronic SA | Capnostream 20 and Capnostream 20p Bedside Patient Monitors | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01102-1 |
| mdprc 061 08 18 000 | Medical Components, Inc | Short Term Haemodialysis Catheters | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01084-1 |
| mdprc 059 08 18 000 | Air Liquide Medical Systems | Matrx Digital MDM Mixer | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01099-1 |
| mdprc 058 08 18 000 | Stryker Europe | Hoffmann LRF Hexapod Software. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01118-1 |
| mdprc 057 08 18 000 | Sage In-Vitro Fertilization Inc | Various in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00594-1 |
| mdprc 056 08 18 000 | Beckman Coulter Inc.. | UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01103-1 |
| mdprc 041 08 18 000 | Medos Medizintechnik AG. | Deltastream Heater-Cooler Unit | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00886-1 |
| mdprc 040 08 18 000 | Elekta Inc | MOSAIQ Medical Oncology version 2.64 SP3 and higher | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01070-1 |
| mdprc 039 08 18 000 | Draeger Medical Systems Inc | Dräger Ceiling Supply Unit; AGILA and Movita Lift Pendants | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01066-1 |
| mdprc 038 08 18 000 | Medtronic SA | BIS Vista and BIS View Monitoring Systems | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01053-1 |
| mdprc 037 08 18 000 | Thermo Fisher Scientific Inc. | PP2030 Mannitol Salt Agar Plates. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01028-1 |
| mdprc 036 08 18 000 | Esaote S.p.A. | MyLab Alpha in combination with IH 6-18 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01043-1 |
| mdprc 011 03 18 001 | Natus Neurology | Natus NicoletOne 32Ch Ambulatory EEG Record System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164231 |
| mdprc 116 07 18 000 | Bio-Rad Laboratories Inc | IH-Com Fullversion & IH-Com for Reader | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01010-1 |
| mdprc 115 07 18 000 | Bio-Rad Laboratories Inc | CFX96-IVD Optical Reaction Module | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01004-1 |
| mdprc 102 07 18 000 | Integra LifeSciences | MAYFIELD Spine Table Adapters and Various Infinity XR2 Base Units | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00912-1 |
| mdprc 025 07 18 001 | B Braun Surgical SA | Safil Sutures | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00737-1 |
| mdprc 070 07 18 000 | LivaNova | Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00929-1 |
| mdprc 067 07 18 000 | Getinge Lancer | GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00906-1 |
| mdprc 054 07 18 000 | Elekta Inc. | Leksell GammaPlan 11.1 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00844-1 |
| mdprc 053 07 18 000 | Medtronic | Guardian Connect Mobile App | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00882-1 |
| mdprc 052 07 18 000 | Olympus | 10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00841-1 |
| mdprc 051 07 18 000 | Philips Healthcare | Patient Supports for Stitching | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00881-1 |
| mdprc 050 07 18 000 | Vygon | Nutriline and Nutriline Twinflo Peripherally inserted central catheters (PICC) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00842-1 |
| mdprc 049 07 18 000 | Vygon | Premicath Neonatal PICC with Stylet | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00478-1 |
| mdprc 026 07 18 000 | Ambu | AMBU Ultraseal II Anaesthetic Mask | http://apps.tga.gov.au/PROD/SARA/arn-detail.a |