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

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    IMMUNO-WASH AUTOMATED TUBE WASHER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BF-NAVI

    FDA 510(k)
    FDA Class 2 ·Radiology

    A.C. SPLINT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 19, 2016

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·April 9, 2015

    HAKIM PROG VALVE INLINE SIPHONGUARD

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF·Product code JXG·June 25, 2014

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 7, 2015

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 29, 2010

    OEC 9800 Systems with 9-inch Image Intensifier

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020