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

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    SAMPLOK LUER KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Safco FG Composhape Finishing Diamonds

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310219413·FG Diamond 801-017 ball extra fine (yellow) 5/pack

    EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088

    FDA 510(k)
    FDA Unclassified ·Unknown

    SYNTHES MODULAR FOOT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code HWC·September 23, 2015

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 26, 2025

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 26, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 25, 2011

    ZENITH FLEX AAA ENDOVASCULAR GRAFT

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code MIH·March 28, 2008

    APPLIANCE, FIXATION, NAIL

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KTT·August 18, 2015

    APPLIANCE,FIXATION,NAIL

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code KTT·October 10, 2016

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 2, 2008

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014