BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    GLIADIN IGA AND GLIADIN LGA

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 15, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code JDI·May 20, 2011

    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 14, 2012

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021