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

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    TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DIRECT TIBC CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    2.0/2.4 CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·May 2, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 26, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·August 1, 2008

    Manifold Custom Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part # K09-07862B, # K09-07873, #K09-02498F, #K09-07828b, #K09-00970J, #K09-06383B, #K09-07002A, #K09-04734D, #K09-00794K, and #K09-08037A.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code DQO·October 1, 2003

    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