| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 025 05 22 000 | Ortho-Clinical Diagnostics | ORTHO VISION and ORTHO VISION Max Analyzers | BfArM |
| mdprc 024 05 22 000 | Siemens Healthcare Diagnostics Product | ADVIA 2120/2120i Hematology Systems. | BfArM |
| mdprc 018 05 22 000 | UROMED Kurt Drews KG | UROMED-Einmal-Nelaton/Tiemann-Katheter | BfArM |
| mdprc 017 05 22 000 | WEINMANN Emergency Medical Technology GmbH + Co.KG | Li-Ion battery for ACCUVAC Pro | BfArM |
| mdprc 010 04 22 000 | Draeger Medical Systems Inc | Infinity CentralStation | BfArM |
| mdprc 006 04 22 000 | Dentsply Sirona, Inc | Teneo Treatment Centers | BfArM |
| mdprc 005 04 22 000 | Osatu S.Coop. | Electrodes for Defibrillation "Bexen Cardio" | BfArM |
| mdprc 004 04 22 000 | Schiller AG | FRED easyport plus defibrillator | BfArM |
| mdprc 045 03 22 000 | Hill Rom Inc | Compella Bariatric Bed Systems and Therapy Air Supply Units | BfArM |
| mdprc 044 03 22 000 | Safe Orthopaedics | Original and Essential Kit Pedicle Screw systems | BfArM |
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 026 05 22 000 | Ossur | VARI-FLEX® JUNIOR | NCMDR |
| mdprc 023 05 22 000 | GE Healthcare | CARESCAPE Central Station (CSCS) V2 | NCMDR |
| mdprc 022 05 22 000 | GE Healthcare | Centricity Universal Viewer Zero Footprint Client (ZFP), Centricity PACS RA1000 Workstation (RA1000), Centricity Radiology RA600 (RA600), Centricity Cardiology CA1000 (CA1000) and Centricity Enterprise Web (CWeb) | NCMDR |
| mdprc 002 05 22 001 | Schwarzer Cardiotek GmbH. | EP-TRACER | NCMDR |
| mdprc 021 05 22 000 | Arrow International Inc. | Arrow 3-Lumen Central Venous Catheters (CVC) Set | NCMDR |
| mdprc 020 05 22 000 | Medtronic SA | EEA Autosuture Circular Stapler with DST Series Technology, 25mm | NCMDR |
| mdprc 016 05 22 000 | Becton Dickinson & Co. (BD) | BD™ Anti-Kappa (TB28-2) APC, BD™ Anti-Kappa (TB28-2) PE | NCMDR |
| mdprc 015 05 22 000 | Becton Dickinson & Co. (BD) | BD OneFlow | NCMDR |
| mdprc 014 05 22 000 | Becton Dickinson & Co. (BD) | BD Connecta™ Stopcock and BD Nexiva™ with BD Connecta™. | NCMDR |
| mdprc 013 05 22 000 | MAQUET Inc. | VOLISTA StandOp Surgical Lights | NCMDR |
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 045 12 20 001 | DiaMed GmbH. | ID-DiaCell; ID-Dia Screen; ID-Dia Panel | Swissmedic, NCMDR |
| mdprc 013 02 22 000 | bioMerieux Inc | VIDAS High sensitive Troponin I | Swissmedic |
| mdprc 023 01 22 000 | Xstrahl Limited | Xstrahl X150 / Gulmay Medical 150 | Swissmedic |
| mdprc 019 01 22 000 | Implantcast | AGILON glenoid components | Swissmedic |
| mdprc 016 01 22 000 | Liko AB | Liko M220, Liko M230 | Swissmedic |
| mdprc 002 03 21 001 | Olympus | OLYMPUS DUODENOVIDEOSCOPE, OLYMPUS EVIS EXERA III DUODENOVIDEOSCOPE, EVIS LUCERA ELITE DUODENOVIDEOSCOPE, and SINGLE USE DISTAL COVER | Swissmedic, BfArM |
| mdprc 004 01 22 000 | MAQUET Cardiopulmonary GmbH | Heater-Cooler Unit HCU 40. | Swissmedic |
| mdprc 002 01 22 003 | D.O.R.C. Dutch Opthalmic Research Center | EFTIAR Octane, syringes and vial, 5 ml and 7 ml | Swissmedic |
| mdprc 001 01 22 000 | Abbott | Alinity m System | Swissmedic |
| mdprc 027 12 21 000 | Abbott | Alinity m System | Swissmedic |
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 012 04 22 000 | bioMerieux Inc | VITEK 2 GP ID Test Kit | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00418-1 |
| mdprc 053 03 22 000 | Philips Healthcare | Philips CombiDiagnost R90 and ProxiDiagnost N90 Systems with software version 1.1.1 or higher | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00344-1 |
| mdprc 051 03 22 000 | Siemens Healthcare Diagnostics | Atellica UAS 800 Urine Sediment Analyser and Atellica 1500 Automated Urinalysis System | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00411-1 |
| mdprc 035 03 22 000 | VOLCANO CORPORATION | IntraSight IVUS Systems | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00490-1 |
| mdprc 033 03 22 000 | Atrium Medical Corporation | Atrium Advanta V12 Covered Stent System | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00419-1 |
| mdprc 032 03 22 000 | Siemens Healthcare Diagnostics Product | Human Chorionic Gonadotropin (HCG) IVD | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00341-1 |
| mdprc 016 03 22 000 | Siemens Healthcare Diagnostics GmbH | Various Assays on Atellica CH 930 Analyzers | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RChttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00302-1 |
| mdprc 007 03 22 000 | SIEMENS | ARTIS icono biplane, ARTIS icono floor, and ARTIS pheno Systems with syngo Application Software | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00307-1 |
| mdprc 027 02 22 000 | Pulsion Medical Systems | PiCCO Monitoring Kit, 150cm line 5/pkg | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00264-1 |
| mdprc 022 02 22 000 | Instrumentation Laboratory SpA | HemosIL AcuStar ADAMTS13 Activity | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00266-1 |
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 019 05 22 000 | SIEMENS | SOMATOM with software syngo CT VA30A_SP4 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192851 |
| mdprc 039 03 22 000 | Bio-Rad Laboratories Inc | BioPlex 2200 SYPH T PACK Syphilis Total & RPR Reagent Pack & BioPlex 2200 Syphilis Total & RPR Calibrator Set CAL | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192210 |
| mdprc 021 03 22 000 | Smiths Medical International Limited. | Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=190636 |
| mdprc 006 03 22 000 | Hill Rom Inc | NaviCare and Voalte Nurse Call Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189999 |
| mdprc 026 12 21 000 | Wright Medical Technology, Inc. | Stryker CLAW II ORTHOLOC and Stryker DARCO Screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=190461 |
| mdprc 019 11 21 000 | Hitachi Ltd. | Arietta 850 Ultrasound; Lisendo 880 Ultrasound | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189705 |
| mdprc 015 11 21 000 | Dentech Corp. | Rubber Dam Clamp, KSK | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187238 |
| mdprc 022 09 21 000 | Siemens Healthcare Diagnostics, Inc | Atellica IM BR 27.29 (BR) Assay 250 Test Kit | US. FDA |
| mdprc 009 09 21 000 | Hitachi Medical Corp | ECHELON MRI System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=188704 |
| mdprc 033 08 21 000 | Pentax of America Inc | Pentax Medical Video Duodenoscope | FDA |