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

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    FOGLESS

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

    NEUROEPG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE

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

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X35MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·March 10, 2021

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 22, 2013

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 8, 2010

    QUARTET

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 9, 2014

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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