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

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    LightStim Professional 2-Panel Light

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

    Oticon

    FDA UDI
    Oticon A/S·05707131286031·NERA2 PRO TI, RITE 312 WL TC

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120465·Guidewire 0.9x150mm Dbl Trocar

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100028·BLUMENTHAL SPECULUM X-HEAVY

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100035·BARRAQUER HEAVY WIRE SPECULUM LARGE

    DDAT OMT

    FDA 510(k)
    FDA Class 2 ·Neurology

    PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE

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

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES GRENCHEN·Product code HRS·January 30, 2017

    FLEXOR ANSEL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code DYB·April 24, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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