BEUDAMED
    20 results · 36ms · Sources: EU EUDAMED, US FDA

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    DUAL ENERGY SYSTEM PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    THE ULTRA SYSTEM SP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EZONO 3000

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·January 6, 2020

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code OTP·May 16, 2013

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    FDA Adverse Event
    Injury ·CONVATEC INC.·Product code NAD·September 29, 2014

    MYNX VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·June 17, 2011

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 22, 2015

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·September 2, 2020

    MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS

    FDA Adverse Event
    Malfunction ·MENTOR TEXAS·Product code LCJ·October 20, 2020

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·May 24, 2022

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·June 27, 2024

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·May 8, 2020

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·May 8, 2020

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·December 9, 2022

    WIRE, SURGICAL

    FDA Adverse Event
    Injury ·DEPUY SYNTHES (USA)·Product code LRN·May 15, 2014

    Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·December 28, 2016

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020