BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS

    FDA 510(k)
    FDA Unclassified ·Unknown

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756104180·FINGER SPLINT

    PASCAL STREAMLINE 577 (WITH ACCESSORIES)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Prudent 1717, Prudent 1417, Prudent 1212

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD SYRINGE S2 5ML 23GA 1-1/4IN BD CHINA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 1, 2022

    ENDO GIA MEDIUM/THICK RADIAL RELOAD

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

    SPHINCTEROTOME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·November 30, 2010

    SPL LEAD, TRANSVENOUS

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

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) 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