BEUDAMED
    11 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.
    Filters Regulation: Us FDA ×

    Intracavitary/Interstitial System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250289200·ceraMotion® Zr Transpa Modifier Value lemon, 20...

    CARDIOLINE HD+

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Michler-Kapp Cardiovascular Vent Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK COMFORT CURVE

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·April 28, 2005

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 3, 2023

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·March 23, 2016

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 6, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·September 15, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015