BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    APAS Independence with Urine Analysis Module

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304271975·

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304465596·

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·May 25, 2023

    GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLAGEN POWDER

    FDA 510(k)
    FDA Unclassified ·Unknown

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·July 29, 2011

    STERNAL ZIPFIX W/NEEDLE PEEK 5U

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JDQ·June 22, 2013

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017