BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Radiology

    HNM Medical

    FDA UDI
    HNM STAINLESS, LLC.·00842962113783·PARKER MOTT RETRACTOR, 6 1/2", DOUBLE ENDED, SE...

    DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

    FDA 510(k)
    FDA Class 2 ·Immunology

    VIRTUOSO SYSTEM FOR IHC HER2 (4B5)

    FDA 510(k)
    FDA Class 2 ·Hematology

    CAPTURE-R READY-SCREEN 3

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·December 22, 2015

    MAXI MOVE

    FDA Adverse Event
    Malfunction ·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·November 5, 2008

    TAXUS (TM) LIBERTÉ (TM)

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 24, 2011

    5MM X 32CM STRYKEPROBE L-TIP

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·July 11, 2013

    BD LUER-LOK TIP SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·August 25, 2020

    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