BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    ZIMMER PATELLOFEMORAL JOINT PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CUFF,DSNEO,CM1500D,7.1-13.1,20 (1ea=20p)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904005263·

    GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    KOALA CLAMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2025

    PLATE BD CHROMAGAR O-157 20 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JSI·August 10, 2021

    PLATE BD CHROMAGAR O-157 20 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JSI·August 10, 2021

    DURASEAL SEALANT SYSTEM 5ML (QTY 5) US

    FDA Adverse Event
    Injury ·CONFLUENT SURGICAL,INC·Product code NQR·January 14, 2010

    2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·April 22, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 27, 2011

    PIC

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·July 2, 2008

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022