BfArM - Federal Institute for Drugs and Medical Devices

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14,953 results

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Urgent Field Safety Notice for CLUNGENE COVID-19 Antigen Rapid Test by Hangzhou Clongene Biotech Co., Ltd. PDF, 4MB, File does not meet accessibility standards Date: 08. January 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 00008/21

Urgent Field Safety Notice for QIAstat-Dx Respiratory SARS-CoV-2 Panel by QIAGEN GmbH PDF, 138KB, File does not meet accessibility standards Date: 08. January 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 22351/20

Urgent Field Safety Notice for 9180 Electrolyte Analyzer by Roche Diagnostics GmbH PDF, 410KB, File does not meet accessibility standards Date: 08. January 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 22188/20

Urgent Field Safety Notice for MODUS and MODUS 2 Pliers by Medartis AG PDF, 529KB, File does not meet accessibility standards Date: 07. January 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 21977/20

Urgent Field Safety Notice for Intellis Clinician Programmer Application by Medtronic Inc PDF, 366KB, File does not meet accessibility standards Date: 06. January 2021 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - programming and control equipment
Reference 22049/20

Urgent Field Safety Notice for TLAB Transjugular Liver Biopsy System by Argon Medical Devices, Inc. PDF, 130KB, File does not meet accessibility standards Date: 06. January 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 22160/20

Urgent Field Safety Notice for Hasson Trocar by Unimax Medical Systems Inc. PDF, 8MB, File does not meet accessibility standards Date: 06. January 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - visceral surgery
Reference 22186/20

Urgent Field Safety Notice for Infusionsfilter 0,2µm by PMH-Produtos Médico Hospitalares, S.A. PDF, 3MB, File does not meet accessibility standards Date: 06. January 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - filters
Reference 17619/20

Urgent Field Safety Notice for APTT S. L Minus / APTT (SILICA) by Helena Biosciences Europe PDF, 2MB, File does not meet accessibility standards Date: 06. January 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 20067/20

Urgent Field Safety Notice for ABL800 with FlexQ by Radiometer Medical ApS PDF, 43KB, File does not meet accessibility standards Date: 06. January 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06171/20

Urgent Field Safety Notice for VITROS Chemistry Products TP & ALB-TP Slides by Ortho-Clinical Diagnostics, Inc. PDF, 371KB, File does not meet accessibility standards Date: 06. January 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10987/20

Urgent Field Safety Notice for LASERFASER Ø 272µM EINWEG by Richard Wolf GmbH PDF, 158KB, File does not meet accessibility standards Date: 05. January 2021 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - laser technology
Reference 21190/20

Urgent Field Safety Notice for Dexcom G6 CGM System by Dexcom, Inc. PDF, 63KB, File does not meet accessibility standards Date: 05. January 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electric blood glucose meters
Reference 20999/20

Urgent Field Safety Notice for NovaLisa Herpes simplex Virus (HSV) 1+2 IgM by NovaTec Immundiagnostica GmbH PDF, 208KB, File does not meet accessibility standards Date: 05. January 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 22156/20

Urgent Field Safety Notice for Pneumococcus CWPS by SSI Diagnostica A/S PDF, 142KB, File does not meet accessibility standards Date: 05. January 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 21634/20

Urgent Field Safety Notice for Finndent FD-8000 Dental Treatment Units by Finndent Oy PDF, 1MB, File does not meet accessibility standards Date: 05. January 2021 Topics: Medical devices Type: Customer information

Product group Dental products - dental treatment units
Reference 19866/20

Urgent Field Safety Notice for therascreen PIK3CA RGQ PCR Kit (24) by QIAGEN GmbH PDF, 51KB, File does not meet accessibility standards Date: 05. January 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 20585/20

Urgent Field Safety Notice for Vanadis Core Buffer kit by Wallac Oy PDF, 7MB, File does not meet accessibility standards Date: 05. January 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - others
Reference 20519/20

Urgent Field Safety Notice for Mölnlycke Procedure Trays & Single Packed Shielded Bladed Trocars by Mölnlycke Health Care AB PDF, 573KB, File does not meet accessibility standards Date: 29. December 2020 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - visceral surgery
Reference 22306/20

Urgent Field Safety Notice for CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MA by Intersurgical Ltd. PDF, 109KB, File does not meet accessibility standards Date: 29. December 2020 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 22147/20

Urgent Field Safety Notice for EliA dsDNA Well by Phadia AB PDF, 83KB, File does not meet accessibility standards Date: 29. December 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 22261/20

Urgent Field Safety Notice for IOLMaster 700 by Carl-Zeiss-Meditec AG PDF, 89KB, File does not meet accessibility standards Date: 28. December 2020 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological diagnostics
Reference 21103/20

Urgent Field Safety Notice for EXOGEN Ultrasound Gel by Bioventus LLC PDF, 399KB, File does not meet accessibility standards Date: 28. December 2020 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - ointments and gels
Reference 22157/20

Updated BfArM recommendation Date: 22. December 2020 Topics: Medical devices Type: Article

BfArM has redacted its updated recommendation from 2019 concerning height-adjustable therapy tables.

Urgent Field Safety Notice for Spinal Rod Cutter by Zimmer Biomet Inc. PDF, 323KB, File does not meet accessibility standards Date: 22. December 2020 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 21877/20

Urgent Field Safety Notice for SENTINEL by Spacelabs Healthcare, Ltd. PDF, 179KB, File does not meet accessibility standards Date: 22. December 2020 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 21633/20

Urgent Field Safety Notice for Atellica COAG 360 System by Siemens Healthcare Diagnostics Products GmbH PDF, 173KB, File does not meet accessibility standards Date: 22. December 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 21234/20

Urgent Field Safety Notice for AEROtube EASYglott Video-Laryngoskop by Shenzhen Besdata Technology Co.,Ltd PDF, 1MB, File does not meet accessibility standards Date: 22. December 2020 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 17052/20

Urgent Field Safety Notice for BEMER-SET classic/pro physikalische Gefäßtherapie by BEMER Int. AG PDF, 27KB, File does not meet accessibility standards Date: 18. December 2020 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 21252/20

Urgent Field Safety Notice for Centricity High Acuity Critical Care by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc PDF, 217KB, File does not meet accessibility standards Date: 18. December 2020 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 21448/20