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

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    CW60N

    FDA 510(k)
    FDA Class 2 ·Radiology

    FASTIN ETHIBOND

    FDA UDI
    DEPUY MITEK, LLC·10886705008247·FASTIN RC Anchor with ETHIBOND w/Needles Titani...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694021111·FPS 2.7mm x 22mm Locking Screw

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111185335·REYNOLDS DISS SCISS CVD 7 SERR

    FPS LAPIDUS PLATE AND LOCKING SCREW

    FDA Adverse Event
    Malfunction ·OSTEOMED·Product code JEY·October 4, 2011

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694075367·FPS 2.7 x 22mm Locking Screw Sterile Qty 5

    PTA AND PTV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160

    FDA 510(k)
    FDA Class 2 ·Immunology

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    SILVERHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code MCW·July 12, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018