BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    NEWPORT LATERAL VAGINAL RETRACTOR

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471145764·SAGITTAL BLADE - DE SOUTTER STANDARD 19 x 55 x ...

    CEMENT SPACERS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    EPILATOR, MODEL CP-16

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SIGMA MODEL SPECTRUM

    FDA Adverse Event
    Malfunction ·SIGMA LLC·Product code FRN·October 22, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2014

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·December 21, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015