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

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    CIBA CORNING ACS HCG IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Total Tool Class A 21 BBP - 16 Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588252773·Total Tool Class A 21 BBP - 16 Poly White

    MICRO-AIRE 4220-000 OSCILLATING SAW

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

    ENDOTRACHEAL CPAP SET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 22, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 10, 2014

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021