BEUDAMED
    9 results · 26ms · 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.

    CHEM-STRATE CK-NAC

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DRIVEMEDICAL

    FDA UDI
    Drive Devilbiss Healthcare·00050428536308·Personal CareAids to Daily Living Product Descr...

    TY RIA KIT, AUTOMATED ASSAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701

    FDA 510(k)
    FDA Class 2 ·Neurology

    ALFA HIP

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code LPH·October 5, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 31, 2013

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2010

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018