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

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    PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 25, 2023

    QUADRA H CEMENTLESS STEM #5 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JDI·May 29, 2015

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·February 4, 2016

    GMK-SPHERIKA 02.07.1204L TIBIAL TRAY FIX CEMENTED S.4L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 10, 2023

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·December 1, 2015

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 28, 2011

    M2A-MAGNUM PF CUP 48ODX42ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 14, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025