BEUDAMED
    7 results · 18ms · 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.

    MULTISPIRO-SX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARD GUARD, MODEL CG-2000A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·January 10, 2013

    PI CVC KIT: 4-L 8.5 FRN X 20 CM AGB

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code FOZ·February 25, 2014

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 18, 2010

    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