BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    Avance Gauze Dressing Kits

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    WINGEATER V2

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

    PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PINN STRAIGHT CUP IMPACTOR

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·October 10, 2014

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 11, 2013

    VISX EXCIMER LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code LZS·April 21, 2011

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·January 19, 2021

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014