BEUDAMED
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    Cardiologs Holter Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RayStation

    FDA 510(k)
    FDA Class 2 ·Radiology

    LaparoVue

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 14, 2014

    REACH JOHNSON & JOHNSON FLOSS FLOURIDE MINT WAXED

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON CONSUMER PRODUCTS·Product code JES·September 16, 2011

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 26, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013