BEUDAMED
    17 results · 38ms · Sources: EU EUDAMED, US FDA

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    Smith and Nephew Legion Hinge Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169502116·INTERBODY 2151118 SMALL - 6 DEG 18MM

    New Image

    FDA UDI
    HOLLISTER INCORPORATED·00610075074167·2-Piece Ostomy Skin Barrier

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304241145·

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613154020393·Posterior Stabilized Tibial Insert

    VARIANT

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1511180·Smooth Fixation Pin, ø3mm x 180mm

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·July 30, 1999

    MODEL TL-360 POWER SCOOTER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ACTIVON TULLE

    FDA 510(k)
    FDA Unclassified ·Unknown

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    STANDARD INSERT

    FDA Adverse Event
    Injury ·DEPUY (IRELAND)·Product code KWA·June 30, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 9, 2008

    AIRVO2 HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 27, 2016

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 9, 2021

    AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Cayenne Medical Inc.·August 1, 2018

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024