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14,979 results

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Urgent Safety Notice for the Spectra Optia Apheresis System, Terumo BCT, Inc. PDF, 54KB, File does not meet accessibility standards Date: 21. October 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures
Reference 04827/13

Corrective action for the EndoWrist® One™ Vessel Sealer, Intuitive Surgical, Inc. PDF, 116KB, File does not meet accessibility standards Date: 21. October 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 06783/14

Corrective action for IMMULITE®/IMMULITE® 1000 Cortisol (LKCO1) assays, Siemens Healthcare Diagnostics PDF, 26KB, File does not meet accessibility standards Date: 21. October 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06548/14

Urgent Safety Notice for the Human IgG Kits for use on the Beckman Immage®, The Binding Site GmbH PDF, 536KB, File does not meet accessibility standards Date: 21. October 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 06373/14

Urgent Safety Notice for the Allura Xper Systems, Philips Healthcare PDF, 388KB, File does not meet accessibility standards Date: 21. October 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 06730/14

Corrective action for the Calcitonin ELISA Kit, Biomerica PDF, 4MB, File does not meet accessibility standards Date: 20. October 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 06140/14

Urgent Safety Notice for the product VarioFit® (cemented), aap Implantate AG PDF, 1MB, File does not meet accessibility standards Date: 20. October 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05777/14

Follow-Up Information for the product Panbio Q Fever IgM ELISA, Standard Diagnostics, Inc. PDF, 10MB, File does not meet accessibility standards Date: 20. October 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04204/14

Recall for the product Disposable Associate Cartridge + Disposable High Speed Vitrectomy Pack, D.O.R.C. International PDF, 1MB, File does not meet accessibility standards Date: 20. October 2014 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 06726/14

Corrective action for Elite XPL (Pulsed Light) Handpiece used with the MPX Laser System, Cynosure, Inc. PDF, 233KB, File does not meet accessibility standards Date: 16. October 2014 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - laser technology
Reference 06723/14

Corrective action for the Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON Access Clinical System, Beckman Coulter PDF, 37KB, File does not meet accessibility standards Date: 16. October 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06674/14

Corrective action for GENESIS II Saw Blades, Smith & Nephew, Inc. PDF, 71KB, File does not meet accessibility standards Date: 16. October 2014 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 06621/14

Urgent Safety Notice for the Patient Data Module (PDM), GE Healthcare PDF, 80KB, File does not meet accessibility standards Date: 16. October 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 06675/14

Corrective action for Varimed - Height adjustable examination and treatment couch, Schmitz u. Söhne GmbH & Co. KG PDF, 11MB, File does not meet accessibility standards Date: 16. October 2014 Topics: Medical devices Type: Customer information

Product group Physical therapy - massage / mobility devices
Reference 06167/14

Safety Notice for the product Compass 3.1, IBA Dosimetry GmbH PDF, 3MB, File does not meet accessibility standards Date: 16. October 2014 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 06710/14

Corrective action for the TRIGEN INTERTAN Lag Screw Length Gauge, Smith & Nephew PDF, 71KB, File does not meet accessibility standards Date: 16. October 2014 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06666/14

Corrective action for recomWell Treponema IgM and ELISA Treponema Cutoff Control IgM (Lot ETP11131), MIKROGEN GmbH PDF, 91KB, File does not meet accessibility standards Date: 15. October 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06579/14

Safety Notice for the alfapump® System, Sequana Medical AG PDF, 128KB, File does not meet accessibility standards Date: 15. October 2014 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - others
Reference 06580/14

Urgent Safety Notice for the FreeStyle Libre Flash Glucose Monitoring System, Abbott Diabetes Care PDF, 705KB, File does not meet accessibility standards Date: 15. October 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electric blood glucose meters
Reference 06440/14

Corrective action for the Enzygnost® Syphilis test plates, Siemens Healthcare Diagnostics Products GmbH PDF, 28KB, File does not meet accessibility standards Date: 15. October 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06319/14

Urgent Safety Notice for the Medi-Trace™ Cadence and Kendall™ Defibrillation Electrodes, Covidien PDF, 93KB, File does not meet accessibility standards Date: 14. October 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 06213/14

Corrective action for Infusion pump CODAN ARGUS 71XV and Syringe pump CODAN ARGUS 606S, CODAN ARGUS AG PDF, 2MB, File does not meet accessibility standards Date: 14. October 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 06275/14

Waldemar Link GmbH & Co. KG: Recall for the Endo-Model® SL® – Connection Component, small PDF, 169KB, File does not meet accessibility standards Date: 14. October 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 06622/14

Recall for HUDSON RCI® Nebulizer Adaptor, Teleflex Medical PDF, 251KB, File does not meet accessibility standards Date: 14. October 2014 Topics: Medical devices Type: Customer information

Product group Physical therapy - inhalation therapy
Reference 05965/14

Safety Information for the Autostainer Link 48 instrument, Dako North America, Inc. PDF, 115KB, File does not meet accessibility standards Date: 13. October 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 05732/14

Corrective action for Floseal Hemostatic Matrix (Floseal VH S/D), Baxter Healthcare PDF, 143KB, File does not meet accessibility standards Date: 13. October 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 06578/14

Corrective action for the Triathlon Tibial Alignment Ankle Clamp EM (Instrument), Stryker® Orthopaedics PDF, 282KB, File does not meet accessibility standards Date: 13. October 2014 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06564/14

Urgent Safety Notice for the product Phorbas, Promedon PDF, 1MB, File does not meet accessibility standards Date: 13. October 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 05412/14

Urgent Safety Notice for the safety scalpel products in Bard Peripherally Inserted Central Catheter (PICC) kits, C. R. Bard, Inc. PDF, 493KB, File does not meet accessibility standards Date: 13. October 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06585/14

Corrective action for VITROS® 4600 Chemistry Systems & VITROS® 5600 Integrated Systems Software Version 3.0 and below, Ortho Clinical Diagnostics PDF, 173KB, File does not meet accessibility standards Date: 13. October 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05872/14