BEUDAMED
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    VisAble.IO

    FDA 510(k)
    FDA Class 2 ·Radiology

    PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TERASON USMART3300 ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    HEX SCREWDRIVER

    FDA Adverse Event
    Injury ·BIOMET SPORTS MEDICINE·Product code HXX·September 1, 2011

    PEEK PREVAIL CERVICAL INTERBODY DEVICE

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·July 22, 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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025