BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    MEDICAM S-4 SURGICAL CAMERA

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228710561·GC Initial™ LF Dentin DB1, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556705275·GC Initial™ LF Dentin DB1, 20g

    NEUTROPHASE WOUND CLEANSER

    FDA 510(k)
    FDA Unclassified ·Unknown

    WAVE Clinical Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 12, 2010

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·December 12, 2012

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MIH·May 1, 2020

    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