BEUDAMED
    13 results · 41ms · Sources: EU EUDAMED, US FDA

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    CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110935·STERILIZING CASE NARROW

    ANTI-K SERIES 2 (HUMAN MONOCLONAL)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·August 21, 2015

    Titan Modular Shoulder System 2.5

    FDA UDI
    Smith & Nephew, Inc.·00885556860212·FIN-LOCK CANNULATED CENTRAL DRILL. M/L

    TITAN™

    FDA UDI
    Ascension Orthopedics, Inc.·10381780258292·Fin-Lock Central Drill

    TITAN™

    FDA UDI
    Ascension Orthopedics, Inc.·10381780258285·Fin-Lock Cannulated Central Drill

    Titan Modular Shoulder System 2.5

    FDA UDI
    Smith & Nephew, Inc.·00885556860229·FIN-LOCK CENTRAL DRILL. M/L

    ACCUSCREEN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AUTOTRANSFUSION SUCTION SET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 23, 2013

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·December 14, 2010

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013