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

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    HYDROCOIL EMBOLIC SYSTEM (HES)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Pilot Spinal System

    FDA UDI
    Life Spine, Inc.·00190837051501·Pilot Flexible Guide Wire (Non Toggle)

    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    3M TEGADERM MATRIX DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014

    PINNACLE MTL INS NEUT36IDX58OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 15, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 3, 2011

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2026

    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