BEUDAMED
    10 results · 20ms · 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 ×

    VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291101635·SS Suture, 6 per sleeve

    3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    I-STAT PROTHROMBIN TIME TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HRS·January 21, 2016

    CERTS INLIN VLV W/UNIT BAC CAT

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC.·Product code JXG·April 8, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·April 5, 2011

    VISTA BASIC

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·May 6, 2008

    ULTRA 2 CUTTING BALLOON

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 4, 2010

    Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·December 11, 2013