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Competent Authorities Composite Listing
BfArM
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 012 12 23 001 | Karl Storz Endoscopy UK Ltd | Multiple products by Karl Storz | BfArM, NCMDR | | mdprc 022 03 22 001 | SIEMENS | ARTIS Q, ARTIS Q.Zen, ARTIS Q Zeego, ARTIS Zeego, ARTIS ZEE | NCMDR | | mdprc 018 05 23 001 | Illumina Inc | NextSeq 550 Dx and MiSeq Dx instruments | BfArM | | mdprc 042 08 23 000 | HAMILTON MEDICAL AG | Hamilton Medical Ventilators HAMILTON-C1/T1/C2/C3 with Neonatal Option | BfArM | | mdprc 024 08 23 000 | Arthrex | KNEE SCORPION | BfArM | | mdprc 021 08 23 000 | Diatron MI Plc | Diacon 3 hematology control ( (Low) 6x, (Normal), (High) 6 ) | BfArM | | mdprc 020 08 23 000 | Ethicon, Inc. | PDS TM II (polydioxanone) Suture, PDS TM Plus Antibacterial (polydioxanone) Suture | BfArM | | mdprc 014 08 23 000 | W.L. Gore & Associates Inc. | Gore tips set | BfArM | | mdprc 012 08 23 000 | Drager Medical Systems Inc | Filter/HME TwinStar® Plus | BfArM | | mdprc 025 07 23 000 | Omixon Biocomputing Ltd. | Omixon HLA Twin | BfArM |
NCMDR
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 019 07 24 000 | Medtronic Inc. | DLP™ Single Stage Venous Cannulae with right angle metal tip | NCMDR | | mdprc 007 05 22 002 | Medtronic XOMED, Inc. | Medtronic NIM™ Standard Reinforced EMG Endotracheal Tube & NIM CONTACT™ Reinforced EMG Endotracheal Tube | NCMDR | | mdprc 018 07 24 000 | Philips Healthcare | HeartStart Intrepid Monitor/Defibrillator | NCMDR | | mdprc 017 07 24 000 | Baxter Healthcare. | PST 500 U Precision Surgical Table | NCMDR | | mdprc 016 07 24 000 | Smith’s Medical International Limited | BLUperc® Percutaneous Dilation Tracheostomy Kit | NCMDR | | mdprc 015 07 24 000 | Zimmer Biomet | CPT Hip System Femoral Stem 12/14 Neck Taper | NCMDR | | mdprc 014 07 24 000 | Abbott Laboratories Inc | Alinity c Proteins Standard | NCMDR | | mdprc 013 07 24 000 | Megadyne Medical Products Inc. | MEGADYNE™ MEGA SOFT™ and MEGA 2000™ Reusable Patient Return Electrodes | NCMDR | | mdprc 012 07 24 000 | OrthoPediatrics Corp | Fassier-Duval Telescopic IM System (FRT250 – 4.0-6.4 CARTRIDGE) | NCMDR | | mdprc 011 07 24 000 | Medtronic XOMED, Inc | NIM Vital Nerve Monitoring System | NCMDR |
SFDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 007 07 24 000 | Saudi Mais for Medical Products | 3-Way Stopcock with/witout Extension Tube. | SFDA | | mdprc 002 06 24 000 | SECURED MEDICAL DIRECTION UK CO., LTD | SMD Disposable Infusion Set | SFDA | | mdprc 032 05 24 000 | SAHHA FACTORY COMPANY FOR SOLUTION MEDICAL PREPARATIONS | VAGINAL EXAMINATION GEL | SFDA | | mdprc 031 05 24 000 | SAHHA FACTORY COMPANY FOR SOLUTION MEDICAL PREPARATIONS | SACO LUBRICANT GEL, 5ml | SFDA | | mdprc 012 04 24 000 | Yiwu Lemaidi Network Technology Co., Ltd. | Minigood Warm Body Stickers / body warmer patch | SFDA | | mdprc 011 04 24 000 | Saudi Mais for Medical Products | 3-Way Stopcock with 10cm Tube | SFDA | | mdprc 010 04 24 000 | Shifaa United for Medical Devices | DMD sodium hypochlorite 5.25% | SFDA | | mdprc 006 04 24 000 | Saudi Mais for Medical Products | Hemocure | SFDA | | mdprc 003 04 24 000 | Hubei MEIBAO Biotechnology Co., Ltd. | G-Care HCG Pregnancy Test | SFDA | | mdprc 015 03 24 000 | Madar rubber factory | Madary Disposable Latex Examination Gloves | SFDA |
Swissmedic
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 030 08 21 002 | Acutronic Medical Systems AG. | fabian HFO, fabian +nCPAP evolution, fabian Therapy evolution | Swissmedic, NCMDR, BfArM | | mdprc 013 06 21 001 | Boston Scientific Corporation | INGENIO, VITALIO, and ADVANTIO pacemakers and INLIVEN, INTUA, and INVIVE cardiac resynchronization therapy pacemakers (CRT-Ps) | Swissmedic, NCMDR | | mdprc 005 02 20 007 | Roche Diagnostics Corp | Elecsys CA 19-9 | NCMDR | | 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 |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 001 10 23 000 | ICU Medical, Inc | Plum 360 Infusion System | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00607-1 | | mdprc 004 09 23 000 | Shenzhen Mindray Bio-medical Electronics Co., Ltd, | SV600/800 Mindray Ventilator | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00730-1 | | mdprc 002 09 23 000 | Siemens Medical Solutions | ACUSON Redwood 2.0 ultrasound systems - 18L6 transducer | TGA | | mdprc 039 08 23 000 | Ortho-Clinical Diagnostics | ORTHO Sera Anti-Lea Murine Monoclonal IgM. | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00742-1 | | mdprc 018 08 23 000 | Instrumentation Laboratory SpA, a Werfen Company | ACL TOP | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00591-1 | | mdprc 011 08 23 000 | Draeger Medical Systems Inc | Babyleo TN500 IncuWarmer | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00352-1 | | mdprc 016 10 22 001 | Siemens Healthcare Diagnostics GmbH | Atellica CH 930 Analyzer, Lithium and Lithium_2 | BfArM | | mdprc 002 08 23 000 | Bio-Rad Laboratories Inc | Liquichek Pediatric Control. | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00649-1 | | mdprc 029 07 23 000 | Ventana Medical Systems | UltraView Universal AP Red Detection Kit | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00561-1 | | mdprc 033 03 22 001 | 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 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 027 06 23 000 | SIEMENS | Luminos Agile Max.
Luminos dRF Max | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199944
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199947 | | mdprc 021 05 23 000 | DermLite LLC | DERMLITE DL4W | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199376 | | mdprc 039 12 22 000 | Hill Rom Inc | Hill-Rom Progressa Bed System | FDA | | mdprc 021 09 22 001 | Philips Healthcare | DigitalDiagnost C50 1.1 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195576 | | mdprc 019 09 22 000 | ICU Medical, Inc. | MicroClave | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195578
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195579
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195572
http://www.accessda | | mdprc 017 09 22 000 | ICU Medical, Inc | ChemoLock Closed System Drug Transfer Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195731
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195036 | | mdprc 021 06 22 001 | Instrumentation Laboratory SpA, a Werfen Company | ACL TOP 300 CTS, ACL TOP 350 CTS, ACL TOP 500 CTS, ACL TOP 550 CTS, and ACL TOP 970 CL | FDA, NCMDR | | mdprc 011 07 22 000 | Diagnos Inc. | CARA (Computer Assisted Retinal Analysis) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192285 | | 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 |
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