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

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    COULTER ELECTROLYTE ANALYZER SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Austin Miller Large External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CATHETER, CARDIAC PACING, ENDOCARDIAL

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MSD BARTLETT MFG·Product code HWX·April 30, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2012

    HALF DAY INFUSOR, 5ML/HR 12PK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 3, 2010

    6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020