BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    PELNAC Bilayer Wound Matrix

    FDA 510(k)
    FDA Unclassified ·Unknown

    Bernafon

    FDA UDI
    Bernafon AG·05711584086667·ZR3, KIT 312 2.4G NFM 75 R BE ZERENA 3

    3D SCANNER, MODEL 1230

    FDA 510(k)
    FDA Class 2 ·Radiology

    EIDOSMED, MODEL EDG4.0

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PY PACING LEAD

    FDA Adverse Event
    Injury ·SULZER OSCOR INC.·Product code DTB·February 8, 1998

    CRYOVALVE

    FDA Adverse Event
    Injury ·CRYOLIFE, INC.·Product code MIE·September 25, 1998

    2.5 REACH DILATATION BALLOON

    FDA Adverse Event
    Injury ·BAXTER·Product code GBA·August 12, 1992

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013

    INTROCAN SAFETY

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FOZ·July 29, 2011

    BOWER RING PEG SYSTEM

    FDA Adverse Event
    Death ·CORPAK, INC.·Product code KGC·November 17, 1992

    PHARMACIA

    FDA Adverse Event
    Injury ·PHARMACIA·Product code LKG·July 20, 1992

    RED DOT MONITORING ELECTRODE

    FDA Adverse Event
    Injury ·MINNESOTA MINING MANUFACTURING COMPANY (3M)·Product code DRX·March 26, 1992

    ALCON SURGICAL

    FDA Adverse Event
    Injury ·ALCON SURGICAL·Product code HQC·June 22, 1992

    TORCON BLUE CATHETER

    FDA Adverse Event
    Death ·THE COOK GROUP·Product code DQX·June 1, 1992

    RADIFOCUS GUIDEWIRE M

    FDA Adverse Event
    Death ·TERUMO CORPORATION·Product code DQX·May 21, 1992

    WHIRLPOOL BATHING UNIT

    FDA Adverse Event
    Injury ·CENTURY MANUFACTURING·Product code ILJ·July 27, 1992

    RADIFOCUS GUIDEWIRE M

    FDA Adverse Event
    Death ·THE TERUMO CORPORATION·Product code MKI·July 24, 1992

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016