BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Response 5.5 Spine System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ASR XL TAP SLV ADAP 9/10+0

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·November 19, 2014

    VASOVIEW 7 XS

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 30, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·August 1, 2013

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014