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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
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
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 115 04 19 000MacoPharma ACDA Anticoagulant Solution http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00633-1
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 113 04 19 000Integra LifeSciencesLimiTorr 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 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 111 04 19 000Carestream HealthCarestream Onsight 3D Extremity System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00628-1
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 084 04 19 000Cook MedicalPericardiocentesis Catheter Set http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00568-1
mdprc 083 04 19 000Accuray 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 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 078 04 19 000Boston ScientificAuriga 30 Laser 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 061 04 19 000Arc Laser GmbHWolf 445nmhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00550-1
mdprc 087 02 19 001OlympusOlympus Duodenovideoscope NCMDR
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 031 03 19 000BioFire 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 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 008 03 19 000Biomet 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 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 069 01 19 002Medtronic Adapta Dual Chamber Pacemakers https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170377
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 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 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 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.a