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

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    The Plateau-LO Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100820·FLIERINGA FIXATION RING 21MM

    SMI CARDIOVASCULAR PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM WITH MMS, MODEL 8XXX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 18, 2024

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 16, 2012

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·July 6, 2017

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·July 6, 2017

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 15, 2011

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·September 23, 2008

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·October 23, 2017

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·October 23, 2017

    GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·October 20, 2017

    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