BEUDAMED
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    FIRMap Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEKSELL GAMMAPLAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    KALIX II IMPLANT, MODEL 141 0XX WITH XX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DTE·June 8, 2013

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, IRVINE·Product code OAD·June 17, 2011

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.,·Product code LGW·September 8, 2008

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·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