BEUDAMED
    19 results · 30ms · Sources: EU EUDAMED, US FDA

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    PHAROS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vivid PMMA Standard System

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724Q2501701·98x25 A2

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111672·Modular Stem 17mm x 100mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690192596·Distal Reamer 17mm (Zimmer)

    Stage 1

    FDA UDI
    KEYSTONE DENTAL, INC.·D768S2501701K0·COC Abutment

    SpineNet SSP System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FORTOSS VITAL BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Dental

    ONE TOUCH BASIC ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 1, 2002

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·December 14, 2001

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 3, 2016

    PACEMAKER AND LEAD

    FDA Adverse Event
    MEDTRONIC, INC.·Product code DXY·January 29, 1996

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 13, 2015

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 5, 2011

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Enforcement
    Class II ·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 6, 2014

    HOMECHOICE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 15, 2011

    MIDLINE CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code LJS·July 24, 2013

    EVOLUT FX DCS

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NPT·July 15, 2025

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Recall
    Open, Classified ·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025