BEUDAMED
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    WHOOP ECG (electrocardiogram) Feature (1.0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Theranos Herpes Simplex Virus-1 IgG Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 23, 2024

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·November 7, 2008

    UNKNOWN DEPUY 36 X 8.5 ART HEAD

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code KWY·September 12, 2011

    STELLARIS 23G VITRECTOMY CUTTER

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·July 19, 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