BEUDAMED
    17 results · 32ms · Sources: EU EUDAMED, US FDA

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    Yumizen C1200 CRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    Bernafon

    FDA UDI
    Bernafon AG·05711584086674·ZR3, KIT 312 2.4G NFM 75 L BE ZERENA 3

    UNKNOWN PEDICLE SCREW

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code MCV·February 23, 1998

    RAPID PROGRAMMER, VERSION 3.3.0

    FDA 510(k)
    FDA Class 2 ·Neurology

    VIPER SYSTEM, EXPEDIUM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DANEK PLATE AND SCREW

    FDA Adverse Event
    Injury ·SOFAMOR DANEK MANUFACTURING·Product code KWQ·February 19, 1999

    TSRH SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·SOFAMOR DANEK MANUFACTURING·Product code KWP·May 19, 1999

    STRETCHER

    FDA Adverse Event
    Injury ·MIDMARK·Product code INK·June 11, 1993

    ALPHA I INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·MENTOR UROLOGY, INC.·Product code FHW·November 8, 1996

    OT VERIO IQ METER

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

    TENDRIL STS

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

    TOTALCARE

    FDA Adverse Event
    HILL-ROM, INC.·Product code FNL·July 29, 2011

    BONE GROWTH STIMULATOR

    FDA Adverse Event
    ELECTRO-BIOLOGY, INC.·Product code LOE·February 7, 1994

    PINNACLE INTRODUCER SHEATH AND GLIDECATH CATHETER

    FDA Adverse Event
    Injury ·TERUMO·Product code DQO·December 27, 1993

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code GFD·October 10, 2012

    COMPANION - VOLUME VENTILATOR

    FDA Adverse Event
    Death ·PURITAN BENNETT·September 22, 1993

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012