BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    FDA UDI
    Kalitec Direct LLC·B07330K0134100·Trial, TLIF, 27L OB STR 7Deg, 10mm

    AT HOME DRUG TEST, MODEL 9064

    FDA 510(k)
    FDA Unclassified ·Unknown

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033484913·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0104100·Caddie Lid, Tulip and Domino Connectors

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033484937·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033484920·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0130100·Segmental Rod Reducer Assembly

    JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONCENTRIC RETRIEVER, MODEL 90030

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARCOS 16X150MM SPL TPR DIST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 21, 2020

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·May 21, 2020

    UNKNOWN CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 21, 2020

    UNKNOWN HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·May 21, 2020

    EVOLUTION(TM) MP CS INSERT

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JWH·March 20, 2013

    ALLURA XPER FD20

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZI·February 2, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019