BEUDAMED
    11 results · 28ms · 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.

    EXACTRAC X-RAY X-RAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    Oticon

    FDA UDI
    Oticon A/S·05707131243140·K220, CIC2 10 BE KIT

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319720349·Iris Tissue Forceps 4" (10cm), full curved, 1x2...

    MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GE VIVID 3 EXPERT; GE VIVID 3 PRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 10, 2011

    ACRYSOF

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·August 15, 2008

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

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

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