BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    DESS Dental Smart Solutions

    FDA 510(k)
    FDA Class 2 ·Dental

    LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM

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

    AF541 EE Full Face Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·November 14, 2008

    SERFAS ENERGY 90 S

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY·Product code GEI·September 1, 2011

    GYNECARE TVT-AA ABDOMINAL

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·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

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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