BEUDAMED
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    syngo.via MI Workflows; Scenium; syngo MBF

    FDA 510(k)
    FDA Class 2 ·Radiology

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517453891·SpheRx II Staple, Medium Inferior

    MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Powder Free Nitrile (Black) Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·November 14, 2014

    PENTA PADDLE LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·September 14, 2011

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS, INC·Product code LZG·July 29, 2013

    Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·September 19, 2018

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014