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

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    Cardio P1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139232626·Up Rod

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517194145·MaXcess Access Blade, 150mm Left

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·00810116022588·600 micron core/730 micron OD SMA Diode Laser F...

    VK Couture

    FDA UDI
    Diversified Products, Inc.·00842894182178·

    HEMOBAG, MODEL HBBSD2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CURA COMPENSATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 1, 2025

    GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 29, 2025

    GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 24, 2025

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 23, 2025

    COBAS 6000 C501MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 12, 2008

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·August 26, 2011

    DELTA CER HEAD 12/14 36MM +8.5

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code LZO·July 17, 2013

    COMPR SRS 60MM DST HUM BDY LT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDC·March 14, 2017

    BIOMET CC I-BEAM TRAY 71MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 27, 2017

    COMPR SRS IC SEG - 60MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·March 14, 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