BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    n/a

    FDA UDI
    Ortho Development Corporation·00822409079582·Trial 15 Degree Liner 22x56mm

    SMARTMONITOR 2PS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TheraCem

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNCHRON URIC ACID

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code KNK·June 10, 2011

    SMARTMONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILLIPS RESPIRONICS - CHMV·Product code FLS·February 21, 2014

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 17, 2025

    ULTRASOFT LANCING DEVICE

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code FMK·December 8, 2008

    INFUSO.R.

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 23, 2011

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    FDA Adverse Event
    Injury ·GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·July 31, 2013

    SMARTMONITOR 2 PROFESSIONAL SERIES

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code FLS·August 23, 2013

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·July 10, 2019

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·September 4, 2013

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·October 11, 2013

    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