BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    SureLock W Suture Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131284280·H11V2 TI, BTE 13 WL 85 STG

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304240834·

    ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS

    FDA 510(k)
    FDA Class 2 ·Dental

    ZUTRON COLONOSCOPE STIFFENING DEVICE

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

    TOTAL ASR ACET IMP SIZE 60

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 6, 2013

    ASR ACETABULAR IMPLANT 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·June 30, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    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