BEUDAMED
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    PC ECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517638380·CoRoent Ant TLIF PEEK, 16x11x30mm 12°

    Mouthpiece, Disposable, 1.02" ID, 2.55" Length

    FDA UDI
    A-M SYSTEMS, LLC·00817081023299·Mouthpiece, Disposable, 1.02" ID, 2.55" Length

    DIGITAL PRINTER P6000D SERIES, MODEL P6000DU

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALEUTIAN IBF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLEXTEND

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·July 13, 2011

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·June 11, 2013

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·September 15, 2008

    Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.

    FDA Enforcement
    Class III ·Terminated·ELITech Group B.V.·October 9, 2019

    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

    GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025