BEUDAMED
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    NXPRO Neuromuscular Electrical Stimulation Device

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776175665·BIERER OVUM FCPS . JAW wo Rat

    MultiPulse HoPLUS

    FDA UDI
    Asclepion Laser Technologies GmbH·04058784001054·Holmium Laser for Surgery (100W-75Hz)

    BEL-CAT

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·May 15, 2018

    ANEURX ABDOMINAL STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA IRELAND·Product code MIH·July 29, 2011

    RADIOLUCENT TRANSVERSE CERVICAL RETRACTOR

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GAD·June 26, 2013

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·September 26, 2008

    SUBDURAL ELECTRODE

    FDA Adverse Event
    Malfunction ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GYC·August 18, 2025

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018

    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