BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    B & B I/A HANDPIECE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Archon

    FDA UDI
    Nuvasive, Inc.·00887517311276·Archon Screw, 4.5x17mm S.T. Fixed

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799006134·

    AUTOMATIC BLOOD PRESSURE DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Senhance Surgical System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 18, 2014

    BIOGLIDE VENTRICULAR CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY, INC.·Product code JXG·October 14, 2010

    HARMONIC SYNERGY* CURVED BLADE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 20, 2012

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024