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

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    CERAMIC TIPPED SKULL PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291101710·SS Suture, 6 per sleeve

    ETEST MEROPENEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    LIBERTY CYCLER

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·August 23, 2011

    PROPAQ MD DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code LDD·March 12, 2013

    9400

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 15, 2011

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·May 7, 2008

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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