BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556704131·GC Initial™ AL Shoulder Transpa ST-36, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228740821·GC Initial™ Ti Enamel Intensive EI-12, 20g

    QUEST BETA HCG ENZYME IMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PORTA-POLE TM MEDICAL EQUIPMENT POLE W/FOLD

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DYONICS 25

    FDA Adverse Event
    Injury ·OKLAHOMA CITY MANUFACTURING SITE·Product code HAB·June 16, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·October 15, 2010

    OMNI(TM) MULTIUSE HANDPIECE

    FDA Adverse Event
    Malfunction ·TRIMEDYNE, INC.·Product code GEX·December 14, 2012

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015