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

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    ATEC Lateral Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Agilis HisPro Steerable Catheter With Electrodes

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2014

    INTERA 1.5T MASTER/NOVA

    FDA Adverse Event
    Injury ·PHILIPS HEALTHCARE·Product code LNH·August 17, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·July 17, 2013

    VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·February 27, 2025

    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024