BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    United Urologics Intermittent Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Oxford Partial Knee System

    FDA UDI
    Biomet Uk Ltd·05019279073061·Anatomic Meniscal Bearing Right Medial

    SOMNOFIT

    FDA 510(k)
    FDA Class 2 ·Dental

    JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 5, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 11, 2013

    Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries Inc·April 21, 2021