BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    PHACO 20/20 SYSTEM I

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ZARA EXTENDED CHIN IMPLANT

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

    CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 27, 2020

    MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·January 10, 2013

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 18, 2010

    SPRING WIRE GUIDE COMPONENT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code LFJ·February 25, 2014

    The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL092002515 Humeral Stem Trial, 15mm TRL092002516 Humeral Stem Trial, 16mm

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·May 2, 2018