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14,965 results

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Urgent Field Safety Notice for EEA Circular Stapler with Tri-Staple Technology by Covidien llc PDF, 203KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 10913/18

Urgent Field Safety Notice for Unity Drill Assembly Unit, .021 Green by Coltene/Whaledent, lnc. PDF, 778KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group Dental products - instruments
Reference 06947/18

Urgent Field Safety Notice for Accu-Chek Inform II, cobas h 232 POC, CoaguChek Pro II, CoaguChek XS Plus/XS Pro by Roche Diagnostics GmbH PDF, 482KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - others
Reference 10894/18

Urgent Field Safety Notice for NOVA FA (POL YRAD PREMIUM CSAP) by SEDECAL S. A. PDF, 109KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 08306/18

Urgent Field Safety Notice for Aptio Automation / StremaLAB Automation by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 88KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10919/18

Urgent Field Safety Notice for Alinity s System by Abbott GmbH & Co. KG PDF, 102KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 11088/18

Urgent Field Safety Notice for cobas e411 by Hitachi High-Technologies, Medical Systems QA Group PDF, 532KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10869/18

Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH & Co. KG PDF, 117KB, File does not meet accessibility standards Date: 10. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 10917/18

Urgent Field Safety Notice for Various brand of IV catheter by Mediplus (India) Linited PDF, 16MB, File does not meet accessibility standards Date: 06. September 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 11227/18

Urgent Field Safety Notice for Y-Ventil by Sunny Medical Device (Shenzhen) Co., Ltd. PDF, 95KB, File does not meet accessibility standards Date: 06. September 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 08740/18

Urgent Field Safety Notice for Xper Flex Cardio Physiomonitoring System by Philips Medical Systems PDF, 32KB, File does not meet accessibility standards Date: 05. September 2018 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 11168/18

Urgent Field Safety Notice for s.pump by Medos Medizintechnik AG PDF, 385KB, File does not meet accessibility standards Date: 05. September 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10547/18

Urgent Field Safety Notice for CyberKnife Robotic Radiosurgery System by Accuray Incorporated PDF, 151KB, File does not meet accessibility standards Date: 04. September 2018 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 11094/18

Urgent Field Safety Notice for AlarisT/ AsenaT CC, GH Syringe Pump by BD Switzerland Sarl PDF, 306KB, File does not meet accessibility standards Date: 04. September 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 11065/18

Urgent Field Safety Notice for Intrafix SafeSet Standard, 180 cm by B. Braun Melsungen AG PDF, 85KB, File does not meet accessibility standards Date: 04. September 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion kits
Reference 11093/18

Urgent Field Safety Notice for General Impactor by Stanmore Implants Worldwide Ltd PDF, 489KB, File does not meet accessibility standards Date: 04. September 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06436/18

Urgent Field Safety Notice for AlignRT by VisionRT Ltd PDF, 774KB, File does not meet accessibility standards Date: 04. September 2018 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 10211/18

Urgent Field Safety Notice for AWC-Additional Working Channel by Ovesco Endoscopy AG PDF, 386KB, File does not meet accessibility standards Date: 04. September 2018 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 10241/18

Urgent Field Safety Notice for Leica M525 by Leica Microsystems (Schweiz) AG PDF, 2MB, File does not meet accessibility standards Date: 03. September 2018 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 10513/18

Urgent Field Safety Notice for Mayfield tracker by Scopis GmbH PDF, 141KB, File does not meet accessibility standards Date: 31. August 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10922/18

Urgent Field Safety Notice for EO-150 Ventilator by EOVE PDF, 110KB, File does not meet accessibility standards Date: 31. August 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 09693/18

Urgent Field Safety Notice for Sterile single use electrosurgical pencil by Wickimed (Huizhou) Medical Equipment Manufacturing Co Ltd PDF, 93KB, File does not meet accessibility standards Date: 30. August 2018 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 06360/18

Urgent Field Safety Notice for T.E.S.S Glenoid Drill 5mm by Biomet France SARL PDF, 335KB, File does not meet accessibility standards Date: 29. August 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 10873/18

Urgent Field Safety Notice for Grip Strapper by Liko AB PDF, 296KB, File does not meet accessibility standards Date: 29. August 2018 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 10585/18

Urgent Field Safety Notice for Zenith Alpha Thoracic Endovascular Graft by William Cook Europe ApS PDF, 72KB, File does not meet accessibility standards Date: 29. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 10222/18

Urgent Field Safety Notice for NeoBase Succinylacetone Assay Solution by PerkinElmer Life and Analytical Sciences, Wallac Oy PDF, 31KB, File does not meet accessibility standards Date: 29. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10614/18

Urgent Field Safety Notice for Taenia solium IgG ELISA by IBL International GmbH PDF, 167KB, File does not meet accessibility standards Date: 29. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 10735/18

Urgent Field Safety Notice for VITROS 5600 Integrated System by Ortho-Clinical Diagnostics, Inc. PDF, 1MB, File does not meet accessibility standards Date: 29. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10428/18

Urgent Field Safety Notice for IgG4 Food screen 280 ELISA by IBL International GmbH PDF, 508KB, File does not meet accessibility standards Date: 29. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10149/18

XSDs for direct reporting from manufacturer databases into XML zip, 28KB, File does not meet accessibility standards Date: 28. August 2018 Topics: Medical devices Type: Form

SAE: XSDs for manufacturers, who wish to report directly from their database into an XML file that fulfils the requirements for electronic reporting.