BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    XTRA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131553·TiBase SS NNC .5G E

    SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPINEFRONTIER LUMBAR IBF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 5, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 15, 2026

    GOLDVAC SMOKE EVACUATION PENCIL WITH ROCKER SWITCH

    FDA Adverse Event
    Injury ·CONMED ELECTROSURGERY·Product code GEI·October 1, 2014

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·May 16, 2013

    RELIA DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NVZ·June 16, 2011

    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Enforcement
    Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015