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

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    FUJIFILM Video Laparoscope EL-R740M30

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 9, 2021

    JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021

    NATURAL KNEE II ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·October 24, 2014

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·August 5, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    VANGUARD(TM) DCM CR TIBIAL BEARING ARCOM UHMWPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 3, 2018

    VANGUARD(TM) CR FEMERAL RIGHT - INTERLOK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 3, 2018

    BIOMET SERIES A STANDARD PATELLA - ARCOM UHMWPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 3, 2018

    OSS RS 7 CM ELLIP SEG FMRL-LT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·September 1, 2016

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023