BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    UCLA AND UNIVERSAL ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    SCANDINAVIAN IVF SCIENCES AB, G2.2

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 21, 2024

    PRECISION NOVI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 16, 2020

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 3, 2020

    PLATE BD CHROMAGAR O-157 20 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JSI·August 10, 2021

    PLATE BD CHROMAGAR O-157 20 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JSI·August 10, 2021

    OBTAPE TRANSOBTURATOR SLING

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code OTN·April 12, 2013

    BIPOLAR

    FDA Adverse Event
    Injury ·SMITH AND NEPHEW, INC.·Product code KWY·April 27, 2011

    ASCENSIA CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 1, 2008

    CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·September 17, 2014

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022