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

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    LUMAGEM MOLECULAR BREAST IMAGING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ROSA SURGICAL DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    JRNY BCS PAT RESRF RD 35 MM STD

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 30, 2017

    REMSTAR AUTO A-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·November 13, 2025

    PELVICOL 2CM X 7CM 1.0MM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE SCIENCE·Product code FTL·April 18, 2013

    ARRAY

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code MFK·June 2, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·August 14, 2008

    JOURNEY POLY TIBIAL INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·June 12, 2017

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025

    Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code MBI·April 23, 2019

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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