BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    MOUNTAINEER OCT SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517283429·CoRoent® Large MP, 8x9x28 8°

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607733·STERIS-AMSCO 1080/2080 W/LEG EXTENSION 3" STANDARD

    WAVEWRITER ALPHA PRIME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 8, 2024

    HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    E-POLY TIBIAL BEARINGS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·July 12, 2017

    LIFEVEST WCD 4000 SYSTEM

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

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 25, 2014

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·July 21, 2008

    COROENT

    FDA Adverse Event
    Malfunction ·NUVASIVE, INC.·Product code MAX·September 15, 2025

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018