BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    THE KEYMED VARI-HEIGHT PATIENT COUCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209119639·

    NCIRCLE TIPLESS STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FFL·January 22, 2019

    YAG MIR FAMILY LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEMSTR 7 THPY ALT ST

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 4, 2014

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 30, 2012

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code LZG·September 27, 2010

    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024