BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    OPHTA SIL (R), LACHRYMAL INTUBATION SETS

    FDA 510(k)
    FDA Unclassified ·Unknown

    N1 TiUltra TCC Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Spectra Q

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

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·January 7, 2013

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·November 30, 2010

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548380 (XMD P/N 70-0050-514) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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