BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    LuxCreo Dental Night Guard Resin

    FDA 510(k)
    FDA Unclassified ·Unknown

    Para 12® Plus

    FDA UDI
    STRECK, INC.·30844509000199·Para 12® Plus is an assayed hematology control ...

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776325879·Punch Biopsy Forcep, straight

    GS Medical AnyPlus PEEK Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GAMBRO POLYFLUX, MODEL 140H, 170H, 210H

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

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·August 11, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 16, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025