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

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    PACEL(TM) FLOW DIRECTED PACING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909141852·REVELATION DIAMOND KS1-012SC - 5 PACK

    SYNCHRON (R) SYSTEMS CREATININE REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CGX·July 2, 2011

    AOS CANNULATED BONE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SENSATRACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 1, 2010

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·July 3, 2014

    10MM, 33CM PEEK MONOPOLAR HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code KOG·December 7, 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