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

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    Orbit Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Oticon

    FDA UDI
    Oticon A/S·05707131280374·RIA2 PRO, BTE 13 WL 85 CBE DEMO

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613154020324·Posterior Stabilized Tibial Insert

    ADMIRAL XTREME PTA BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EASYSTIM NMS-28

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OT PING METER

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

    AUGMENTED INSERT

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code KWA·June 29, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 3, 2008

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    NESTER PLATINUM EMBOLIZATION MICROCOIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    STAINLESS STEEL EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·August 24, 2017

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    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