BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    ROCHE OXI/FERM II

    FDA 510(k)
    FDA Class 1 ·Microbiology

    IN VITRO GAMMACOAT B-HCG RADIO. TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Disposable Safety Lancets

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

    SCREWDRIVER BIHEX Ø3 W/T-HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·January 22, 2013

    DORO

    FDA Adverse Event
    PRO MED INSTRUMENTS, GMBH·Product code HBL·December 7, 2010

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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

    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026