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

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    INJECTION NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BDH UNIPOLAR FEMORAL COMPONENT A2

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOW PROFILE STEERABLE BALLOON DILATA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GIA 60-3.8 SINGLE USE RELOADABLE STAPLER

    FDA Adverse Event
    Death ·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GDW·May 19, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 15, 2012

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 10, 2010

    ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·August 14, 2019

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015