BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    HeartBeam AIMIGo(TM) System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Split Cath®

    FDA UDI
    Medical Components, Inc.·00884908089240·14F X 24CM Split Cath® CATHETER SET (CUFF 19CM ...

    EBI SPINELINK SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIPLATFORM MEDICAL IMAGING SUITE

    FDA 510(k)
    FDA Class 2 ·Radiology

    JDEVOLUTION PLUS

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·September 12, 2025

    IMP TM 4.7MM MTX FULL, 10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·April 8, 2021

    IMP TM 4.7MM MTX FULL, 10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 3, 2023

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 18, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

    ACUVUE ADVANCE PLUS BRAND CONTACT LENSES

    FDA Adverse Event
    Injury ·VISTAKON·Product code LPL·July 15, 2013

    IMP TM 4.7MM MTX FULL, 10

    FDA Adverse Event
    Injury ·ZIMVIE US CORP LLC·Product code DZE·October 29, 2025

    EQUINOXE HUMERAL LINER

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·October 2, 2024

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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