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

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    BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100691·MAUMENEE-PARK SPECULUM SOLID

    ADP REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    X-T AIR DRILL

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OPEN PIVOT AP MITRAL HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWQ·July 28, 2021

    PUMP MMT-722LNAB PRDGM INS BL EN ML

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·November 30, 2010

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 15, 2014

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·December 5, 2012

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015