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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 038 08 18 001Medtronic BIS Vista and BIS View Monitoring SystemsNCMDR
mdprc 012 07 19 001Varian Medical SystemsStainless Steel Interstitial Needles, 17 Gauge http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01003-1
mdprc 008 03 19 001Biomet 3i Inc. 3.4mm Certain BellaTek Abutment, ILDAT3https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171233
mdprc 089 05 19 001Apollo Endosurgery Inc.Orbera Intragastric Balloon System and BIB Intragastric Balloon System https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00675-1
mdprc 009 08 19 000SIEMENSMAMMOMAT Revelation VC10 with Biopsy Option http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01129-1
mdprc 008 08 19 000Mesa Laboratories, Inc.EZTest H202 Biological Indicators http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01128-1
mdprc 007 08 19 000Cincinnati Sub-Zero Products Inc.Norm-O-Temp Hyperthermia System, MICRO-TEMP LT System, Blanketrol II Hyper-Hypothermia System, Blanketrol III Hyper-Hypothermia System and CoolBlue Hyper-Hypothermia System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01127-1
mdprc 006 08 19 000Allergan services international LimitedTextured Breast Implants and Tissue Expandershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01116-1
mdprc 115 07 19 000Henry Schein, Inc.KaVo RONDOflex Powder 27µm 1000g to be used with the KaVo RONDOFLEX plus 360 air abrasion system http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01123-1
mdprc 105 07 19 000Terumo BCT IncSpectra Optia Apheresis System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01111-1
mdprc 104 07 19 000SIEMENSSOMATOM Definition Edge , SOMATOM Definition AS, SOMATOM Definition Flash, with syngo http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01083-1
mdprc 103 07 19 000SIEMENSBiograph mCT and mCT Flow systems running PETsyngo VG70A http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01114-1
mdprc 102 07 19 000Medicrea International.PEEK Cervical Cages and PEEK Lumbar Cageshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01105-1
mdprc 101 07 19 000Cooper Surgical, Inc.TRANSWARMER Warming Infant Transport Mattresses.http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01106-1
mdprc 097 07 19 000SPIGGLE & THEIS MedizintechnikPanetti ENT endoscopic ear instrumentshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01102-1
mdprc 096 07 19 000Radiometer America IncRadiometer ABL90FLEX blood gas analyser and Radiometer AQT90FLEX immunoassay analyser https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01093-1
mdprc 077 07 19 000GE HealthcareFluorostar 7900 System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01085-1
mdprc 076 07 19 000HEIDELBERG ENGINEERING GmbHHEYEX 2 image management components of SPECTRALIS PC Software http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01065-1
mdprc 075 07 19 000Phadia LtdImmunoCAP Tryptase Control http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01091-1
mdprc 074 07 19 000QIAGEN LtdQIAsymphony SP instrument (Software 5.0.3) http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01096-1
mdprc 031 03 19 001BioFire Diagnostics Inc.FilmArray Gastrointestinal (GI) Panel.NCMDR
mdprc 064 07 19 000Getinge GETINGE Steam Steriliser http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01071-1
mdprc 043 07 19 000Phadia LtdPhadia 1000 instrument http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01055-1
mdprc 042 07 19 000Morcher GmbHMorcher Capsular Tension Rings Type 13 Right, Type 13A Right and Type 13B Right http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00995-1
mdprc 041 07 19 000BD BiosciencesBD Connecta Plus3 White (3 way stopcock) http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01049-1
mdprc 038 07 19 000GE HealthcareMAC VU360 systems http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01054-1
mdprc 026 07 19 000Nuvasive Specialized Orthopaedics Inc.MAGEC System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01014-1
mdprc 025 07 19 000Cyclomedica Australia Pty LtdTechnegasPlus Generator http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01023-1
mdprc 058 05 19 001Siemens Healthcare Diagnostics Creatine Kinase on the Atellica Chemistry platform https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173277
mdprc 011 07 19 000Beckman CoulterAQUIOS IMMUNO-TROL Low Cells http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01033-1
mdprc 037 05 19 001Baxter HealthcarePrismaflex devices with software version 8.10 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00691-1
mdprc 092 06 19 000Medical Innovation Developpement SASMID-Tube, Orogastric calibration Tubehttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00985-1
mdprc 089 06 19 000Arjo HuntleighTenor Passive Floor Lifthttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00978-1
mdprc 018 06 19 001Teleflex MedicalSheridan Endotracheal Tubeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173225
mdprc 069 06 19 000RSR LtdACHRAb RIA kits. http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00918-1
mdprc 068 06 19 000ZimmerComprehensive Reverse Shoulder Instrument Caseshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00922-1
mdprc 050 06 19 001Becton Dickinson & Co. (BD)Microtainer TubesSwissmedic
mdprc 053 06 19 000Terumo BCT IncSpectra Optia Apheresis System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00878-1
mdprc 052 06 19 000Randox Laboratories Ltd.Assayed Bovine Multi-Sera - Level 1 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00917-1
mdprc 051 06 19 000Magic MobilityMagic mobility wheelchair - Mobility Handles http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00907-1
mdprc 049 06 19 000Beckman CoulterSYNCHRON Systems Phosphorus Reagent (PHOSm) http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00916-1
mdprc 083 04 19 001Accuray Inc.CyberKnife M6 and CyberKnife VSI Secondary Collimation Subsystem https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172287
mdprc 017 06 19 000QIAGEN LtdFilter-Tips, 1500 µl (1024) used with QIAsymphony SP/AS Instruments http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00857-1
mdprc 016 06 19 000Philips HealthcarePhilips Incisive Computed Tomography x-ray system http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00847-1
mdprc 015 06 19 000CODAN Medizinische Geraete GmbH & Co KGCodan Extension Set https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00813-1
mdprc 014 06 19 000Nanjing Mindray Bio-Medical Electronics Co., Ltd.HyLED Surgical Light Series 7, 8 and 9 https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00764-1
mdprc 013 06 19 000Pride Mobility Products LtdJ623 Power Wheel Chairs ("Jazzy 623") fitted with Dynamic Controls Shark Power Module https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00797-1
mdprc 012 06 19 000Beckman Coulter UK LtdUniCel DxH 800/600/900 Coulter Cellular Analysis System. https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00808-1
mdprc 056 08 18 001Beckman Coulter Inc..UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171361
mdprc 114 05 19 000Aidacare Pty LtdTilt & Recline Shower Commode: Aspire, 46cm and 53cm https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00736-1
mdprc 113 05 19 000GE HealthcareLVivo EF app on Vscan Extend https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00765-1
mdprc 112 05 19 000Nidek Co. Ltd.CEM-530 Specular Microscope https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00789-1
mdprc 111 05 19 000SIEMENSMAGNETOM Vida and Sola with syngo MR XA11 software https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00773-1
mdprc 113 04 19 001Integra LifeSciencesLimiTorr Volume Limiting External CSF Drainage and Monitoring Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172225
mdprc 092 05 19 000Change HealthcareMcKesson Cardiology Hemo Systemshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00745-1
mdprc 091 05 19 000MedicinaENFit NGP and Ryles Nasogastric Feeding Tubes https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00754-1
mdprc 090 05 19 000Beckman Coulter UK LtdPower Express Sample Processing Systemhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00756-1
mdprc 081 05 19 000Ivor Shaw Limited As Peninne HealthcareVarious Gastric Tubes and Catheters https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00746-1
mdprc 059 05 19 000Siemens Healthcare Diagnostics Creatine Kinase on the ADVIA Chemistry platform http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00732-1
mdprc 057 05 19 000Medtronic O-Arm 1000 Imaging Systemshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00728-1
mdprc 115 04 19 001MacoPharma ACDA Anticoagulant Solution http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00633-1
mdprc 051 05 19 000Medtronic Medtronic HeartWare Monitor AC Adapter http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00703-1
mdprc 059 08 18 001Air Liquide Medical SystemsMatrx Digital MDM Mixerhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00663-1
mdprc 038 05 19 000MAKO Surgical 2.7 Degree Angled Sagittal Saw attachment and 2.7 Degree Straight Sagittal Saw attachment http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00680-1
mdprc 078 04 19 001Boston ScientificAuriga 30 Laser System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00565-1
mdprc 061 04 19 001Arc Laser GmbHWolf 445nmhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00550-1
mdprc 028 05 19 000Edwards LifescienceslntroFlex lntroducers http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00683-1
mdprc 027 05 19 000C R Bard Inc.EnCor Breast Biopsy Probeshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00664-1
mdprc 026 05 19 000Beckman CoulterIMMAGE Immunochemistry Systems Immunoglobulin M (IGM) Reagent http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00688-1
mdprc 021 05 19 000Sysmex Corporation Sysmex SP-50 slidemaker-stainer http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00672-1
mdprc 020 05 19 000SIEMENSSOMATOM go.Up, SOMATOM go.Now, SOMATOM go.All, SOMATOM go.Top http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00667-1
mdprc 019 05 19 000Covidien Monoject Standard Hypodermic Needles http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00671-1
mdprc 009 05 19 000ZimmerAlvarado Knee Holder Base Plate Assemblies and Foot Pieces and Alvarado II Base Plates and Foot Pieceshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00660-1
mdprc 146 04 19 000SIEMENSBiograph Vision 600 and Biograph Vision 600 Edge (with VG75A or B software and the PATLAK reconstruction license) https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00650-1
mdprc 111 04 19 001Carestream HealthCarestream Onsight 3D Extremity System https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171699
mdprc 084 04 19 001Cook MedicalPericardiocentesis Catheter Set http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00568-1
mdprc 062 04 19 001Beaver Visitec International LtdVisiwipe Instrument Wipe 73 x 73mmBfArM
mdprc 116 04 19 000Teleflex Medical Rüsch Lasertubeshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00606-1
mdprc 114 04 19 000Istanbul Medikal LtdMedwarm neonate and Medwarm neonate with Skin temp port and probe http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00643-1
mdprc 112 04 19 000DiaSorin Inc.Liaison XL and Liaison XL LAS with POM Stirrer Bar M http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00579-1
mdprc 097 04 19 000Stryker Berchtold CHROMOPHARE F 528 and F 628 Surgical Light System Light Head Covershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00575-1
mdprc 086 04 19 000Oxoid Ltd OXOID MICE Strip MA0122 – Ceftriaxone32 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00573-1
mdprc 085 04 19 000Direct Healthcare Services LtdMercury Advance V1 Control Unit http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00563-1
mdprc 082 04 19 000AbbottTactiSys Quartz Equipment operating http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00571-1
mdprc 079 04 19 000Cincinnati Sub-Zero Products Inc.CSZ Haemotherm 400CE System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00565-1
mdprc 077 04 19 000Baxter HealthcareMicrobore Y-Type Extension Set and Catheter Extension Set with Clearlink http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00567-1
mdprc 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 Clinic