BfArM - Federal Institute for Drugs and Medical Devices

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Urgent Field Safety Notice for Medihoney by Derma Sciences, inc (in process in transitioning to Acell) PDF, 411KB, File does not meet accessibility standards Date: 13. January 2026 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - ointments and gels
Reference 01040/26

Urgent Field Safety Notice for Raucotupf Sttu gr Wako 50x2, sterile by Goodwood Medical Care Ltd. PDF, 539KB, File does not meet accessibility standards Date: 13. January 2026 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - swabs, sponges, wipes, swabsticks
Reference 63515/25

Urgent Field Safety Notice for NGSengine by Genome Diagnostics B.V. PDF, 865KB, File does not meet accessibility standards Date: 13. January 2026 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 61776/25

Urgent Field Safety Notice for SHOCKPULSE LITHOTRIPSY TRANSDUCER. by Gyrus ACMI - Olympus - OSTA PDF, 468KB, File does not meet accessibility standards Date: 13. January 2026 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic therapeutic equipment
Reference 49565/25

Guidance for Applicants Scientific Advice PDF, 259KB, File does not meet accessibility standards Date: 13. January 2026 Topics: About BfArM Type: Download

Guidance for Applicants Scientific Advice

Urgent Field Safety Notice for Philips CT systems by Philips Medical Systems Nederland B.V. PDF, 956KB, File does not meet accessibility standards Date: 12. January 2026 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 00862/26

Urgent Field Safety Notice for Hand Files: K+-Flex, Triple-Flex, K+-Files, Hedstrom, Reamers by Kerr Italia S.r.l. PDF, 307KB, File does not meet accessibility standards Date: 09. January 2026 Topics: Medical devices Type: Customer information

Product group Dental products - instruments
Reference 53431/25

Urgent Field Safety Notice for GM Helix Implant, Ti, 4.0X13 by JJGC Indústria e Co.ércio de Materiais Dentários S.A. PDF, 216KB, File does not meet accessibility standards Date: 09. January 2026 Topics: Medical devices Type: Customer information

Product group Dental products - dental implants
Reference 59865/25

Urgent Field Safety Notice for Leksell GammaPlan by Elekta Solutions AB PDF, 158KB, File does not meet accessibility standards Date: 09. January 2026 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 60270/25

Urgent Field Safety Notice for Azurion by Philips Nordic PDF, 1MB, File does not meet accessibility standards Date: 08. January 2026 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 58792/25