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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 101 11 18 001Medtronic Suction/Anticoagulation Assembly LinesBfArM
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 027 12 18 000Shimadzu Medical Systems.Digital Angiography System Trinias http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01487-1
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 130 10 18 000GE HealthcareCARESCAPE R860 Inspiratory Safety Guardhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01398-1
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 049 10 18 000Baxter HealthcareEXACTAMIX Empty EVA Bagshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01333-1
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 087 09 18 000Baxter HealthcareAK 98 Hemodialysis Devices http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01233-1
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 095 08 18 000OlympusOlympus Bronchofiberscopes, Bronchovideoscopes, Bronchofibervideoscopes, Ultrasonic Bronchofibervideoscopes, Rhino-laryngo Videoscopes and Airway Mobilescopeshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01145-1
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 060 08 18 000MAKO Surgical CorpMako Vizadiscs and Vizadisc Hip Tracking Kithttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01129-1
mdprc 059 08 18 000Air Liquide Medical SystemsMatrx Digital MDM Mixerhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01099-1
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 056 08 18 000Beckman Coulter Inc..UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systemhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01103-1
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 038 08 18 000Medtronic SABIS Vista and BIS View Monitoring Systemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01053-1
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 080 10 17 001Radiometer Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00081-1
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 069 01 18 001Beckman CoulterFC 500 Series Flow Cytometershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00051-1
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