BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    EASYLYTE CALCIUM/CHLORIDE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Rooti Rx ECG Event Recorder, Rooti Link APP Software

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 6, 2014

    ASR XL TAP SLV ADAP 12/14+2

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·February 15, 2013

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·December 21, 2010

    2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024