BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    DRF 4343

    FDA 510(k)
    FDA Class 2 ·Radiology

    OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    THE LIBERATOR WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code ESW·March 25, 2015

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    RX HERCULINK 14 STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code FGE·May 6, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 12, 2013

    LYME EIA

    FDA Adverse Event
    Injury ·BIO-RAD·Product code LSR·September 6, 2014

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FAD·March 12, 2015

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code ESW·November 12, 2014

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code ESW·November 27, 2014

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code ESW·November 24, 2014

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024