BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.
  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

14,950 results

Results per page: 10 20 30

Urgent Field Safety Notice for Ingenia Elition, MR 7700 by Philips Medical Systems Nederland B.V. PDF, 3MB, File does not meet accessibility standards Date: 01. December 2022 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 31507/22

Urgent Field Safety Notice for MYRIAN by Intrasense PDF, 1MB, File does not meet accessibility standards Date: 01. December 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 31669/22

Urgent Field Safety Notice for Biopsy Forceps S. by Endo-Flex GmbH PDF, 325KB, File does not meet accessibility standards Date: 30. November 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 32003/22

Urgent Field Safety Notice for Saug- und S.ülinstrumente by Dewimed Medizintechnik GmbH PDF, 255KB, File does not meet accessibility standards Date: 30. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 30680/22

Urgent Field Safety Notice for ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE by Olympus Medical Systems Corp. PDF, 445KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 30430/22

Urgent Field Safety Notice for Centricity PACS IW by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc PDF, 258KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 30968/22

Urgent Field Safety Notice for Liver Assist Perfusion Set by XVIVO B.V. PDF, 524KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 31487/22

Urgent Field Safety Notice for AXIOM Iconos R100; R200 C20+C90; AXIOM Luminos TF by Siemens Healthcare GmbH Advanced Therapies PDF, 349KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 31024/22

Urgent Field Safety Notice for Oncentra Brachy by Nucletron BV PDF, 192KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 31881/22

Urgent Field Safety Notice for HUGO Bipolar Fenestrated Grasper by Covidien llc PDF, 177KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 18670/22

Urgent Field Safety Notice for Presage ST2 Assay by Critical Diagnostics PDF, 640KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 19697/22

Urgent Field Safety Notice for CM root canal posts Reamer (White) Post size 1 by Cendres & Métaux PDF, 193KB, File does not meet accessibility standards Date: 29. November 2022 Topics: Medical devices Type: Customer information

Product group Dental products - instruments
Reference 28364/22

Urgent Field Safety Notice for IMMULITE 2000 and IMMULITE 2000 XPi 3gAllergy Specific IgE by Siemens Healthcare Diagnostics Products Ltd. PDF, 163KB, File does not meet accessibility standards Date: 28. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 30542/22

Urgent Field Safety Notice for Glyde File Prep Doses Pack by Maillefer Instruments Holding SARL PDF, 524KB, File does not meet accessibility standards Date: 28. November 2022 Topics: Medical devices Type: Customer information

Product group Dental products - instruments
Reference 30102/22

Urgent Field Safety Notice for VACSII 22x40 Cardiac valvuloplasty catheter by OSYPKA AG PDF, 326KB, File does not meet accessibility standards Date: 28. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 31664/22

Urgent Field Safety Notice for Sensis, Sensis Vibe Combo, Sensis Vibe Hemo by Siemens Healthcare GmbH, Advanced Therapies Angiographie PDF, 1MB, File does not meet accessibility standards Date: 25. November 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 30639/22

Urgent Field Safety Notice for Catheter Repair Kits (Various) by Bard Access Systems Division (BASD) PDF, 473KB, File does not meet accessibility standards Date: 25. November 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 31492/22

Urgent Field Safety Notice for Guardian Connect Application by Medtronic Minimed PDF, 216KB, File does not meet accessibility standards Date: 25. November 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 31266/22

Urgent Field Safety Notice for NextAR Shoulder System by Medacta International SA PDF, 666KB, File does not meet accessibility standards Date: 24. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 28629/22

Urgent Field Safety Notice for Atellica IM Free Prostate-Specific Antigen (fPSA) by Siemens Medical Solutions Diagnostics PDF, 179KB, File does not meet accessibility standards Date: 24. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 31473/22

Urgent Field Safety Notice for IMMULITE 2000, IMMULITE 2000XPi by Siemens Healthcare Diagnostics Ltd PDF, 267KB, File does not meet accessibility standards Date: 23. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 21027/22

Urgent Field Safety Notice for Small Joint OATS Set Autograft Diameter 8 / 6 mm by Arthrex Inc. PDF, 694KB, File does not meet accessibility standards Date: 23. November 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 30389/22

Urgent Field Safety Notice for Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e by Maquet Critical Care AB PDF, 385KB, File does not meet accessibility standards Date: 23. November 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 29748/22

Urgent Field Safety Notice for MIS CANNULATED POLYAXIAL SCREW by CLARIANCE PDF, 470KB, File does not meet accessibility standards Date: 23. November 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 28258/22

Urgent Field Safety Notice for SYNGO RT THERAPIST in combination with ARTISTE MV by Siemens Healthcare GmbH, Advanced Therapies, Radiation Oncology PDF, 654KB, File does not meet accessibility standards Date: 23. November 2022 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 30410/22

Application for a decision on the authorisation requirement of a clinical trial of a medical device or a performance study of an in vitro diagnostic medical device Date: 22. November 2022 Topics: Medical devices Type: Article

If the regulatory classification of a planned clinical investigation or performance study cannot be clarified, the parties involved in the conduct, authorisation or monitoring of the clinical investigation / performance study may submit an …

Which powers of attorney should be included with the application? Date: 22. November 2022 Topics: Medical devices Type: FAQ

In the case of an application for authorisation of a clinical investigation under the MDR or a performance study under the IVDR, a power of attorney for the legal representative of the sponsor in the Union (cf. Article 62 (2) and (4) (c) MDR or …

Urgent Field Safety Notice for Dimension Vista Magnesium Flex reagent cartridge by Siemens Healthcare Diagnostics Inc. Newark PDF, 283KB, File does not meet accessibility standards Date: 22. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03198/22

Urgent Field Safety Notice for Elecsys CA 19-9 by Roche Diagnostics GmbH PDF, 131KB, File does not meet accessibility standards Date: 22. November 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00936/20

Urgent Field Safety Notice for Assurity, Endurity by Abbott Sylmar PDF, 191KB, File does not meet accessibility standards Date: 22. November 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 16448/22