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

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    DIRECT HDL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981224·anteriors; shade B4; mould BM6

    Symmetry

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482086841·Symmetry® Forceps, Grasping, w/Cup, Slide Lock ...

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·December 9, 2015

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·January 8, 2016

    METER, FLOW, PEAK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    XPS HANDPIECE - VISAO

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·November 2, 2021

    DRILL 3334800 VISAO 80K HANDPIECE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ERL·July 2, 2013

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017

    BI-METRIC HIP LATERALISED FEMORAL STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·March 2, 2017

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 27, 2013

    TRAPEASE PERMANENT VENA CAVA FILTER 55CM

    FDA Adverse Event
    Malfunction ·CORDIS EUROPA, N.V.·Product code DTK·February 8, 2011

    SILTEX MAMMARY PROTHESIS

    FDA Adverse Event
    Injury ·MENTOR TEXAS, INC.·Product code FTR·July 24, 2014

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·June 9, 2016

    LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 20, 2024

    The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·June 3, 2009

    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