BEUDAMED
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    COSGROVE MITRAL VALVE RETRACTOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    APPOSE ULE STERILE DISPOS. SKIN STAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    H.R. JAKOBI SURG. INSTRUMENTS #4 30/31

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·June 2, 2014

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FSA·November 25, 2012

    JAGWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code EZB·September 24, 2010

    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·December 13, 2023

    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