BfArM - Federal Institute for Drugs and Medical Devices

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14,950 results

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Information on the admissibility of data processing outside Germany in connection with the review procedure of the BfArM pursuant to Section 139e German Social Code Book V (SGB V) PDF, 567KB, File does not meet accessibility standards Date: 11. October 2023 Topics: Medical devices Type: Download

Information on the admissibility of data processing outside Germany in connection with the review procedure of the BfArM pursuant to Section 139e German Social Code Book V (SGB V)

Urgent Field Safety Notice for Instrument Arm Drape by Intuitive Surgical, Inc. PDF, 314KB, File does not meet accessibility standards Date: 10. October 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 30279/23

Urgent Field Safety Notice for Siluron 1000 and Siluron 2000 and SiluronXtra by Fluoron GmbH PDF, 339KB, File does not meet accessibility standards Date: 10. October 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - liquid media for ophthalmological purposes
Reference 30253/23

Urgent Field Safety Notice for Klinion Kliniray by Medeco B.V. Bleiswijk PDF, 294KB, File does not meet accessibility standards Date: 10. October 2023 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 29871/23

Urgent Field Safety Notice for MEERA EU with/without Drive Unit by Maquet GmbH PDF, 696KB, File does not meet accessibility standards Date: 10. October 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 23983/23

Urgent Field Safety Notice for MiniMed 780G Insulin Pump by Medtronic Minimed PDF, 132KB, File does not meet accessibility standards Date: 09. October 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 30097/23

Urgent Field Safety Notice for Atrium Ocean Water Seal Chest Drain by Atrium Medical Corporation Merrimack PDF, 141KB, File does not meet accessibility standards Date: 09. October 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 29371/23

Urgent Field Safety Notice for MAGIX 2 by New Live Mobilité PDF, 581KB, File does not meet accessibility standards Date: 09. October 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 21804/23

Urgent Field Safety Notice for C3 CryoSonde by Inomed Medizintechnik GmbH, Emmendingen PDF, 130KB, File does not meet accessibility standards Date: 06. October 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 27975/23

Urgent Field Safety Notice for Sentiero, Sentiero Screening 2 by PATH MEDICAL GmbH PDF, 26KB, File does not meet accessibility standards Date: 06. October 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - ENT equipment
Reference 29238/23

Urgent Field Safety Notice for SapphireT Multi-Therapy by Eitan Medical Ltd PDF, 568KB, File does not meet accessibility standards Date: 05. October 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 28149/23

Urgent Field Safety Notice for THUNDERBEAT by Olympus Medical Systems Corp. PDF, 332KB, File does not meet accessibility standards Date: 05. October 2023 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic therapeutic equipment
Reference 28691/23

Urgent Field Safety Notice for DESCOSEPT SENSITIVE WIPES by Dr.Schumacher Gmbh PDF, 746KB, File does not meet accessibility standards Date: 05. October 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 07347/23

Urgent Field Safety Notice for Level 1 H-2 Pressure Chambers by Smiths Medical ASD, Inc. (Plymouth) is no. part of ICU Medical PDF, 946KB, File does not meet accessibility standards Date: 04. October 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 16718/22

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 446KB, File does not meet accessibility standards Date: 04. October 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - artificial hearts
Reference 21994/20

Urgent Field Safety Notice for Einweg-Patientenschlauchsysteme VENTcirc-MMT by WEINMANN Emergency Medical Technology GmbH + Co. KG PDF, 518KB, File does not meet accessibility standards Date: 02. October 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 28316/23

Urgent Field Safety Notice for Zimmer Dermatome Blades by Zimmer Orthopaedic Surgical Products PDF, 1MB, File does not meet accessibility standards Date: 02. October 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 28443/23

Urgent Field Safety Notice for Reverse Shoulder Prosthesis (RSP) Humeral Socket by Encore Medical, LP (dba DJO Surgical) PDF, 1MB, File does not meet accessibility standards Date: 29. September 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 22772/23

Urgent Field Safety Notice for ENNOVATE by Aesculap AG PDF, 3MB, File does not meet accessibility standards Date: 29. September 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 29079/23

Urgent Field Safety Notice for Humeral reverse metaphysis +0mm/0° by Medacta International SA PDF, 481KB, File does not meet accessibility standards Date: 29. September 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 24635/23

Urgent Field Safety Notice for Senhance Surgical System by Asensus Surgical Italia S.r.l. PDF, 1MB, File does not meet accessibility standards Date: 28. September 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 28306/23

Urgent Field Safety Notice for UniCel DxI 800/600 and Access 2 Immunoassay Analyzer by Beckman Coulter, Inc. PDF, 1MB, File does not meet accessibility standards Date: 28. September 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 26123/23

Urgent Field Safety Notice for Randox G6PDH by Randox Laboratories Ltd PDF, 2MB, File does not meet accessibility standards Date: 28. September 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 29090/23

Urgent Field Safety Notice for Multichem IA Plus controls, Multichem S Plus controls by Techno-path Manufacturing Ltd. PDF, 2MB, File does not meet accessibility standards Date: 28. September 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 26312/23

Urgent Field Safety Notice for Acrobat-i Stabilizer by Maquet Cardiovascular PDF, 206KB, File does not meet accessibility standards Date: 27. September 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - cardiac/thorax surgery
Reference 28444/23

Urgent Field Safety Notice for s.a. safe Disinfection Cap by Fresenius Medical Care AG & Co. KGaA PDF, 140KB, File does not meet accessibility standards Date: 27. September 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 29245/23

Urgent Field Safety Notice for DOSE: Patient radiation dose monitoring software by QAELUM NV PDF, 896KB, File does not meet accessibility standards Date: 26. September 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 23027/23

Urgent Field Safety Notice for NEXUS / PDMS by NEXUS / DIS GmbH PDF, 784KB, File does not meet accessibility standards Date: 25. September 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 27789/23

Urgent Field Safety Notice for Terumo-Platelet Additive Solution + (T-PAS+) by Terumo BCT Europe N.V. PDF, 441KB, File does not meet accessibility standards Date: 25. September 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 26678/23

Urgent Field Safety Notice for RelayPro Thoracic Stent Graft System by Bolton Medical lnc. PDF, 613KB, File does not meet accessibility standards Date: 22. September 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 33177/22