BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768512·GENUMEDI PSS GREEN VII

    ECG Module(AHA)

    FDA UDI
    SAMSUNG MEDISON CO., LTD.·08806167712532·

    ORTHOPEDIC SALVAGE SYSTEM (OSS)

    FDA UDI
    Biomet Orthopedics, LLC·00880304005440·

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304817708·

    AEROSYNC FOR AERODR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    X-SUIT NIR COVERED BILIARY METALLIC STENT

    FDA Adverse Event
    Malfunction ·MEDINOL LTD.·Product code FGE·December 27, 2017

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

    EEA 31MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GDW·June 16, 2011

    NAVILYST MEDICAL

    FDA Adverse Event
    Injury ·NAVILYST MEDICAL (FORMERLY NAMIC/VA)·Product code LJS·September 5, 2008

    OSS INTERLOK BOWED IM STEM WITH SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·November 22, 2019

    ARTOURA BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·August 21, 2023

    ORTHOPEDIC SALVAGE SYSTEM (OSS) SEGMENTAL ELLIPTICAL FEMORAL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 12, 2019

    OSS MOD EXPANDABLE SZ20 SEG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·June 14, 2019

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017