BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    X-RING SEPARATORS

    FDA 510(k)
    FDA Class 1 ·Dental

    44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIGMA High Performance (HP) Partial Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINER AND SHELL WITH PLASTIC BARRIER 48 MM I.D. 60 MM O.D.

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·May 3, 2023

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 25, 2014

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 2, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 8, 2010

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012