BEUDAMED
    8 results · 30ms · 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.

    SIMPEX INC. SURGICAL DRESSING

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

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450595145·

    POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Eko Murmur Analysis Software (EMAS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013

    MICRO RECIPROCATING SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·November 26, 2010

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·July 3, 2014

    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