BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    XANAR MODEL XSE-300 SMOKE EVACULATER

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

    MODEL XLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRESERV GOMORI TRICHROME STAIN 125/500

    FDA 510(k)
    FDA Class 1 ·Hematology

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 2, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·November 24, 2012

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·September 24, 2010

    PINN CAN BONE SCREW 6.5MMX20MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG.·Product code NDJ·October 16, 2014

    PINN MULTIHOLE W/GRIPTION 58MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 16, 2014

    PINN CAN BONE SCREW 6.5MMX35MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG.·Product code NDJ·October 16, 2014

    PINN CAN BONE SCREW 6.5MMX15MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG.·Product code NDJ·October 16, 2014

    CORAIL2 STD SIZE 10

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG. # 30038955·Product code KWA·October 16, 2014

    PINN CAN BONE SCREW 6.5MMX25MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG.·Product code NDJ·October 16, 2014

    12/14 ARTICUL 40MM M SPEC+15.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code LPH·August 16, 2012

    ALTRX +4 10D 40IDX58OD

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code LPH·August 16, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    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