BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    Additive Orthopaedics Bone Wedge System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131292117·ALTA2 PRO, BTE 13 WL 105 SGR

    Bard® Urine Meter with Bag

    FDA UDI
    C. R. Bard, Inc.·00801741040726·Bard® Urine Meter with Bag

    TRUETRACK

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·March 29, 2013

    ARGUS, MODEL LCM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JBAIDS Q FEVER DETECTION KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SNORERX

    FDA Adverse Event
    Injury ·APNEA SCIENCES·Product code LRK·May 22, 2017

    UNKNOWN

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code DXY·June 8, 2013

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 23, 2011

    PINNACLE 100 ACET CUP 52MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·September 4, 2008

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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