BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    HOTDOG PATIENT WARMING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO:ENDIUS BIPOLAR SHEATH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    APEX SPINE SYSTEM W/ COCR RODS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 14, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    CARDIOVASCULAR PROCEDURE KIT

    FDA Adverse Event
    TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTR·April 4, 2011

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021