BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    Ion 3D

    FDA 510(k)
    FDA Unclassified ·Unknown

    OSTEONICS SECUR-FIT-HA PSL CLUSTER ACETABULAR SHELL

    FDA Adverse Event
    Injury ·OSTEONICS CORP.·Product code KWB·November 23, 1998

    OSTEONICS OMNIFIT HA HIP STEM

    FDA Adverse Event
    Injury ·OSTEONICS CORPORATION·Product code KWY·July 27, 1998

    OSTEONICS OMNIFIT 10 DEGREE CUP INSERT-SERIES I

    FDA Adverse Event
    OSTEONICS CORPORATION·Product code KWB·July 27, 1998

    OMNIFIT INTERFACE SPHERICAL ACETABULAR SHELL

    FDA Adverse Event
    Injury ·OSTEONICS CORP.·Product code KWB·July 24, 1998

    nPro Surgical Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Acrylic Block

    FDA 510(k)
    FDA Class 2 ·Dental

    2243265-1997-00002

    FDA Adverse Event
    Injury ·Product code KWY·January 21, 1997

    2243265-1999-00096

    FDA Adverse Event
    Injury ·December 29, 1999

    2243265-1999-00094

    FDA Adverse Event
    Malfunction ·December 21, 1999

    2243265-1999-00095

    FDA Adverse Event
    Malfunction ·December 22, 1999

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 2, 2025

    OSTEONICS OMNIFIT PSL HA ACETABULAR SHELL

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code KWB·March 10, 1999

    OSTEOINICS OMNIFIT PSL HA ACETABULAR SHELL

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code KWB·March 10, 1999

    OSTEONICS OMNIFIT PSL HA ACETABULAR SHELL

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code KWB·March 10, 1999

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 11, 2014

    TREATMENT RECLINER

    FDA Adverse Event
    Malfunction ·GLOBAL·Product code FRK·September 1, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 23, 2013

    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