BEUDAMED
    13 results · 25ms · Sources: EU EUDAMED, US FDA

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    VANCOMYCIN FLUORESCENT IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STRADIS HEALTHCARE

    FDA UDI
    STRADIS MEDICAL, LLC·M7526822308·GENERAL SURGICAL KIT

    SeaSpine Expandable Interbody

    FDA UDI
    Seaspine Orthopedics Corporation·10889981123468·IMPLANT, 22mm LG, 8-12mm HT, 12mm WD, 0 DEG

    Integra Expandable Interbody

    FDA UDI
    Seaspine Orthopedics Corporation·10889981049249·IMPLANT, 22mm LG, 8-12mm HT, 12mm WD, 0 DEG. Th...

    Al Smile Aligner

    FDA 510(k)
    FDA Class 2 ·Dental

    AXSOS DISTAL LATERAL FEMUR TS LONG PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEPUY ASR XL FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 20, 2014

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code FZP·December 6, 2007

    PLASMABLADE TISSUE DISSECTION DEVICE

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·July 30, 2020

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·December 2, 2020

    GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023