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

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    PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BD¿ SYRINGE 10ML LL TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 16, 2020

    POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TRIDENT 10° X3 INSERT 32MM ID

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·May 3, 2013

    DUROM ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·September 4, 2014

    MYSTIQUE GRAFT CONTAINMENT PLATING SYSTEM

    FDA Adverse Event
    Injury ·KENSEY NASH CORP.·Product code KWQ·May 5, 2011

    Ureteral dilator, REF RBD014

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·April 10, 2024

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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