BEUDAMED
    41 results · 31ms · Sources: EU EUDAMED, US FDA

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    POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ILIZAROV

    FDA UDI
    Smith & Nephew, Inc.·03596010029485·5 HOLE LONG PLATE - SMALL BONE FIXATOR

    Digital Analogue NC

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059074413·

    Mini Pull Thru

    FDA UDI
    MEDIVATORS INC.·00677964058592·Mini Pull Thru GI Endoscope Cleaning Brush

    DUREPAIR®

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code GXQ·June 28, 2023

    BONASTENT® Tracheal/Bronchial

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369468145·

    Dukal

    FDA UDI
    Dukal LLC·20665973032591·Pretreat Gauze 4x4, 12ply, Green

    Admiral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981277024·Trial Drill Guide, 9mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450177792·

    Brevis

    FDA UDI
    BICON, LLC·00813110020628·6.0mm 15° Brevis™ Abutment - 2.0mm Post

    Femoral Sizer ML Check

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215041038·

    CBC-SF

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO T-REX BIOPSY FORCEPS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HIGH FREQUENCY VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 15, 2012

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 8, 2013

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER (ISRAEL) LTD.·Product code DQK·September 19, 2014

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Other ·GENTEEL HOMECARE PRODUCTS·Product code ITJ·May 16, 2011

    NOVASURE SURESOUND

    FDA Adverse Event
    Injury ·HOLOGIC, INC.·Product code MNB·May 13, 2021

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·October 26, 2010

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011