BEUDAMED
    10 results · 19ms · 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.
    Filters Regulation: Us FDA ×

    STRATUS CS CARDIAC TROPONIN I TESTPAK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AXSOS

    FDA UDI
    Stryker GmbH·07613154482719·X-Ray Template Compression Plate Broad

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981098·anteriors; shade A3.5; mould IM2

    ENDOBUTTON CONTINUOUS LOOP (CL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACUSON SC2000 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    PD CYCLER 115V, HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 27, 2013

    UNK DEPUY SZ 50 PINNACLE CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·August 5, 2014

    WANDA PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·February 8, 2011

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025