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

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    MECTA-C

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...

    VAPRO PLUS INTERMITTENT CATHETER

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

    NEUROVISION SE (NERVEANA)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    BIPOLAR HEAD Ø22X41

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWY·September 14, 2018

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

    LCS COMPLETE POLY PATELLA STD+

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code NJL·September 24, 2014

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·June 3, 2011

    AMISTEM H HA COATED STD STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 15, 2018

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·November 25, 2024

    BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.

    FDA Enforcement
    Class II ·Ongoing·Becton, Dickinson and Company, BD Biosciences·November 9, 2022

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    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

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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