BEUDAMED
    25 results · 21ms · Sources: EU EUDAMED, US FDA

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    VERDICT PCP

    FDA 510(k)
    FDA Unclassified ·Unknown

    VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000

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

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·May 2, 2014

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·February 15, 2013

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·December 21, 2010

    ACTIV.A.C. THERAPY

    FDA Adverse Event
    Injury ·KCI USA INC.·Product code OMP·June 18, 2015

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 25, 2015

    V.A.C. GRANUFOAM DRESSING

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020

    ACTIV.A.C.¿ THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 12, 2018

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·October 15, 2015

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020