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

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    ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750006830·8411A NON HTD PNT

    SYRINGE CONTROL 10ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 23, 2019

    ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LERMAN & SON CRANIAL ORTHOSIS HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code KWI·January 25, 2017

    BD SYRINGE CONTROL 10ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 11, 2019

    LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 14, 2013

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 24, 2014

    DUR MAR +4 NEUT LNR 36X54

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 18, 2011

    8MM TI STRAIGHT RADIAL STEM 28MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWI·January 24, 2017

    22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWI·January 24, 2017

    18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWI·September 7, 2017

    7MM TI STRAIGHT RADIAL STEM 26MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWI·September 7, 2017

    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