BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    Z BOND, PRELUDE ONE

    FDA 510(k)
    FDA Class 2 ·Dental

    Flexitron

    FDA UDI
    Nucletron B.V.·08717213027169·Flexitron Transfer Tube for 4F Flexibles (24)

    DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2

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

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·March 28, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·February 27, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·March 1, 2013

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·May 30, 2024

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NDN·February 27, 2013

    BLACKMAX-NEURO

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HSZ·May 7, 2013

    *

    FDA Adverse Event
    Malfunction ·BIOPRO, INC.·Product code KWY·May 29, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 12, 2008

    VITEK® 2 AST-ST01 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025