BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    Dorsal Spanning Plate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131281012·NERA2 PRO, MINIBTE 312 WL 85 SGR

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100530·LIEBERMAN SPECULUM V-WIRE

    HNM Women Care

    FDA UDI
    HNM STAINLESS, LLC.·00812171027690·PESSARY, CUBE #4, W/DRAINS, 41mm

    EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EASYRA UREA NITROGEN AND CREATININE REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALT HA S NOCLR EXT SZ 7

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code MEH·September 19, 2023

    APPLIC-INSTR F/STERNAL ZIPFIX

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code JDQ·July 27, 2017

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·June 6, 2013

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·June 22, 2011

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MÉDICAL·Product code OVE·September 21, 2021

    1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    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