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

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    PHYSIOLOGICAL MONITOR, PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nautilus

    FDA UDI
    Life Spine, Inc.·00190837075910·Thoracic Probe

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104745·PS3 Screw 4.5mm x 40mm

    UNIMAX VERESS NEEDLE

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

    ISOLA POLYAXIAL WASHER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BENCHMARK GX, STAINER MODULE

    FDA Adverse Event
    Injury ·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·June 18, 2024

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 15, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 3, 2011

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2018

    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