BEUDAMED
    825 results · 59ms · 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.

    DISTAL ACCESS CATHETER 070

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL, INC.·Product code DQY·February 8, 2012

    MERCI BALLOON GUIDE CATHETER 9F

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL, INC.·Product code DQY·November 29, 2011

    MERCI RETRIEVER V 2.5 FORT

    FDA Adverse Event
    Malfunction ·CONCENTRIC MEDICAL, INC.·Product code NRY·July 26, 2012

    Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.

    FDA Recall
    Terminated ·Concentric Medical Inc·Product code GBS·February 27, 2009

    ALLIGATOR RETRIEVAL

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS D/B/A EV3 NEUROVASCULAR·Product code DQY·May 29, 2020

    VISIONAIRE

    FDA Adverse Event
    Injury ·Product code CAW·March 11, 2021

    VISIONAIRE 5

    FDA Adverse Event
    Injury ·CAIRE INC.·Product code CAW·October 3, 2022

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Enforcement
    Class II ·Terminated·POM Medical LLC·November 6, 2019

    COMPANION 5

    FDA Adverse Event
    Injury ·CAIRE INC.·Product code CAW·December 21, 2023

    *

    FDA Adverse Event
    Malfunction ·CHURCHILL MEDICAL SYSTEMS, INC. CUSTOM TRAY DIV.·Product code FMI·June 13, 2001

    VISIONAIRE 5

    FDA Adverse Event
    Injury ·Product code CAW·July 1, 2021

    ECLIPSE 5

    FDA Adverse Event
    Malfunction ·CAIRE INC.·Product code CAW·November 16, 2018

    NEWLIFE INTENSITY 10

    FDA Adverse Event
    Malfunction ·CAIRE INC.·Product code CAW·June 11, 2020

    VISIONAIRE 5

    FDA Adverse Event
    Death ·CAIRE INC.·Product code CAW·September 14, 2018

    MERCI RETRIEVER V 2.0 SOFT

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL, INC.·Product code NRY·March 7, 2012

    MERCI RETRIEVER V 2.0 FIRM

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL, INC.·Product code NRY·March 13, 2012

    MERCI RETRIEVER V 2.0 FIRM

    FDA Adverse Event
    Malfunction ·CONCENTRIC MEDICAL, INC.·Product code NRY·March 21, 2012

    MERCI RETRIEVER V 2.0 SOFT

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL, INC.·Product code DQY·March 5, 2012

    MERCI RETRIEVER V 2.5 SOFT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL, INC.·Product code NRY·March 7, 2012

    MERCI RETRIEVER V 3.0 FIRM

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL, INC.·Product code NRY·March 7, 2012