BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    STAYFUSE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PED NIH™ Cardio-Marker

    FDA UDI
    MEDTRONIC, INC.·00613994964175·WVN CATH 990804 5PK 6F 100CM PED NIH

    PED NIH™ Cardio-Marker

    FDA UDI
    MEDTRONIC, INC.·00763000200213·WVN CATH 990804 5PK 6F 100CM PED NIH

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red

    AETOS Shoulder System

    FDA UDI
    Smith & Nephew, Inc.·00885556871560·STEM INSERTION DEVICE

    NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HydroCision TenJet Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 5, 2013

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·February 8, 2011

    CARDIA VR

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code LWS·August 8, 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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021