BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    CARESIDE AMMONIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MODEL F-1010 DIGITAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MolecuLight i:X

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

    HDI 5000 ULTRASOUND STANDARD SYSTEM

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 6, 2013

    X8000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·January 26, 2011

    MAXIMO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021