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14,965 results

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German SAE Report Form PDF, 983KB, File does not meet accessibility standards Date: 28. August 2018 Topics: Medical devices Type: Form

Report form for reporting of serious adverse events (SAE) in clinical trials or performance evaluation studies for use by sponsors according to § 3 (5) of the Ordinance on Medical Devices Vigilance

PDF-Form (use of Adobe Acrobat 9.X …

Urgent Field Safety Notice for TrueBeam & EDGE Radiotherapy Delivery Systems by Varian Medical Systems, Inc. PDF, 241KB, File does not meet accessibility standards Date: 24. August 2018 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 10656/18

Urgent Field Safety Notice for Vitality Shear-off Set Screw by Zimmer Biomet Spine, Inc PDF, 397KB, File does not meet accessibility standards Date: 24. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 10706/18

Urgent Field Safety Notice for Geratherm Patient Warming System UniqueTemp° Recovery, Recovery Set 1 by Geratherm Medical AG PDF, 2MB, File does not meet accessibility standards Date: 24. August 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 12015/17

Urgent Field Safety Notice for AMSCO V-PRO 1, V-PRO 1 Plus, VPRO maX by Steris Corporation PDF, 154KB, File does not meet accessibility standards Date: 23. August 2018 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 09195/18

Urgent Field Safety Notice for Affixus Hip Fracture Nail by Biomet Orthopedics, LLC PDF, 371KB, File does not meet accessibility standards Date: 23. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 10586/18

Urgent Field Safety Notice for Multix Fusion by Siemens Shanghai Medical Equipment Ltd. (SSME) PDF, 2MB, File does not meet accessibility standards Date: 23. August 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 09862/18

Urgent Field Safety Notice for BE-HLS 7050#HLS Set Advanced 7.0 by Maquet Cardiopulmonary AG PDF, 30KB, File does not meet accessibility standards Date: 23. August 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10615/18

Urgent Field Safety Notice for Varilymph 12 Pro by SLK Vertriebsgesellschaft mbH PDF, 307KB, File does not meet accessibility standards Date: 22. August 2018 Topics: Medical devices Type: Customer information

Product group Physical therapy - massage / mobility devices
Reference 10137/18

Urgent Field Safety Notice for Cannulated Screw-sterile Lochschrauben by aap Implantate AG PDF, 731KB, File does not meet accessibility standards Date: 22. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 10578/18

Urgent Field Safety Notice for Hiploc Plate by Biomet UK Ltd PDF, 135KB, File does not meet accessibility standards Date: 22. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 10473/18

Urgent Field Safety Notice for Cardioband by Edwards Cardioband PDF, 877KB, File does not meet accessibility standards Date: 22. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 10548/18

Urgent Field Safety Notice for ADVIA Centuar CKMB Calibrator/Atellica CKMB Calibrator by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 423KB, File does not meet accessibility standards Date: 22. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09663/18

Urgent Field Safety Notice for Ergo Just Cart by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) PDF, 179KB, File does not meet accessibility standards Date: 22. August 2018 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - ENT equipment
Reference 06010/18

Urgent Field Safety Notice for DORO LUCENT Base Unit by PMI pro med Instruments GmbH PDF, 12MB, File does not meet accessibility standards Date: 22. August 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 08268/18

Urgent Field Safety Notice for Drill CS 2.7/3.5, ø2.7, L 130, quick coupling by aap Implantate AG PDF, 710KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 10505/18

Urgent Field Safety Notice for Transplant-Aspiration Needle, SPI-CUT by Somatex Medical Technologies GmbH / Berlin PDF, 361KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 10510/18

Urgent Field Safety Notice for AST-P640 Test Kit and AST-P655 Test Kit by bioMérieux Inc PDF, 383KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 10455/18

Urgent Field Safety Notice for Rotating IV pole by GE Healthcare Clinical Systems (Ohmeda Medical) PDF, 381KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 10518/18

Urgent Field Safety Notice for Output Unit by Hitachi, Ltd. PDF, 101KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04106/17

Urgent Field Safety Notice for Oxoid CT0159B by Remel Europe. Part of Thermo Fisher Scientific PDF, 86KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05700/18

Urgent Field Safety Notice for RAPIDPoint 405 500 and RAPIDLab 1245 1265 by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 66KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09283/18

Urgent Field Safety Notice for 611P CT Lucia by Carl-Zeiss-Meditec AG PDF, 217KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 09981/18

Urgent Field Safety Notice for Minicon Clinical Sample Concentrators by Merck Millipore Ltd PDF, 60KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06679/18

Urgent Field Safety Notice for cobas m 511 integrated hematology analyzer by Roche Diagnostics GmbH PDF, 739KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 05666/18

Urgent Field Safety Notice for ARCHITECT EBV VCA IgM Controls by Abbott GmbH & Co.KG PDF, 100KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 09310/18

Urgent Field Safety Notice for power supply for div. sleep therapy devices by Löwenstein Medical Technology GmbH + Co. KG PDF, 115KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 09532/18

Urgent Field Safety Notice for Endocavity Needle Guide by CIVCO Medical Instruments Co., Inc. d.b.a CIVCO Medical Solutions PDF, 71KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - cardiac/thorax surgery
Reference 10372/18

Urgent Field Safety Notice for Direct Radiography system DX-D 600 by Agfa HealthCare N.V. PDF, 187KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 10051/18

Urgent Field Safety Notice for ZNN TIBIAL NAIL by Zimmer Biomet, Inc. Warsaw PDF, 307KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 10159/18