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

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    SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHARPLAN MODELS 100 SERIES C02 LASERS/ACCESSORIES

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

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 22, 2013

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 7, 2010

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·July 9, 2014

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    OT SURESTEP METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 6, 2010

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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