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

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    FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    7600 V MASK

    FDA UDI
    HANS RUDOLPH, INC.·00874750001118·7600 MD FF W/AAV 22OD QREL HDG

    NEO UL Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837044824·Fixed 0 deg Angled Drill Guide

    G-SCAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    1.5T OPTIMA MR430S

    FDA 510(k)
    FDA Class 2 ·Radiology

    JUNI

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·May 15, 2013

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 3, 2011

    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

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 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 L131, ESSENTIO DR EL MRI Pacemaker

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