BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    FOCUS MIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    2810 3WAY SLIDE VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00874750009312·2810A 3W MAN SLDVLV 22MMOD PRT

    APEX MEDICAL LCD TENS-VII

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AQUILEX FLUID CONTROL SYSTEM

    FDA Adverse Event
    Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

    PUMP,INFUSOR WTH 3 SMART LABEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·November 16, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

    ULTRACISION HARMONIC SCALPEL LAPAROSCONIC COAGULATING SHEARS (LCS), SCISSORGRIP

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GEI·August 11, 2008

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 28, 2011

    WALLFLEX? BILIARY TRANSHEPATIC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 21, 2012

    PERCLOSE PROGLIDE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·February 18, 2026

    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