BEUDAMED
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    ST-90 SPIRO ANALIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PHILIPS HeartStart Configure

    FDA UDI
    PHILIPS ELECTRONICS NORTH AMERICA CORPORATION·00884838041547·HeartStart Configure

    DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE

    FDA 510(k)
    FDA Class 2 ·Neurology

    VPAP Adapt SV, VPAP Tx, S9 VPAP Tx

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PROTECTA XT DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014

    FUSION LOOPTIP WIRE GUIDE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KOG·November 28, 2012

    MAXIMO II CRT-D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·October 8, 2010

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012