BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    Philips IntelliVue GuardianSoftware (Rev. E.0X)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Motor BL implant

    FDA UDI
    SIRONA Dental Systems GmbH·E27662122080·Motor BL implant

    NA

    FDA UDI
    Synthes GmbH·10886982152152·5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE...

    ARKEO, Wedge Fixation System

    FDA UDI
    Auxano Medical LLC·00850055649804·ARKEO Evan's Wedge, 22x22x08

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613252252153·2.0MP LEFORT I PLATE,8MM ADVANCEMENT,R

    ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895

    FDA 510(k)
    FDA Class 2 ·Immunology

    INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES

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

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2015

    CORAIL2 LAT COXA VARA SIZE 10

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS-3003895575·Product code KWA·October 30, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023