BEUDAMED
    17 results · 26ms · Sources: EU EUDAMED, US FDA

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    Stryker Neptune 3 Waste Management System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768512·GENUMEDI PSS GREEN VII

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100318·ALPHONSO INFANT SPECULUM

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111068096·SKLHN METZ LAHEY SCISS STR 7"

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100394·MURDOCH EYE SPECULUM #3

    COTRONIC DIGITAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·July 24, 2002

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 16, 2025

    CONTOUR PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 22, 2024

    CONTOUR PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 1, 2023

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 8, 2013

    ENDOTAK DSP

    FDA Adverse Event
    Injury ·GUIDANT PUERTO RICO BV·Product code NVY·July 7, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 10, 2023

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 23, 2023

    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