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

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    SPIRA®-C Integrated Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 20, 2025

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 30, 2025

    RAPID RHINO EPISTAXIS DEVICE

    FDA Adverse Event
    Injury ·ARTHROCARE CORP.·Product code EMX·August 18, 2011

    QUICKSITE XL LV

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 12, 2013

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026