BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    5MP MONOCHROME LCD MONITOR, RADIFORCE GX540

    FDA 510(k)
    FDA Class 2 ·Radiology

    KMEDIC EXTERNAL FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 21, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·July 16, 2013

    Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G

    FDA Enforcement
    Class II ·Ongoing·Apellis Pharmaceuticals, Inc.·October 11, 2023

    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·September 27, 2023