BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    AMBU DISPOSABLE FACE MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    LP Low Profile

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746089039·DB BKT LP LL CUSP 018 T=0 A+3 R=0

    Obtura Spartan

    FDA UDI
    OBTURA SPARTAN ENDODONTICS·00816168020459·EMS Threaded Tip KiS-4E

    Obtura Spartan

    FDA UDI
    Young Innovations, Inc.·00843471100943·EMS Threaded Tip KiS-4E

    ihcDirect® Cytokeratin 5 Ab

    FDA UDI
    NOVODIAX, INC.·00850000596139·Clone R226

    N LATEX IGM

    FDA 510(k)
    FDA Class 2 ·Immunology

    GSB GLOBAL SPINAL BALANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TPRLC 133 MP TYPE1 BM HO 16.0

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 15, 2018

    UNKNOWN ZIMMER FEMORAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·November 30, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 28, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 14, 2014

    INTERLOCKING DETACHABLE COIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KRD·January 12, 2015

    VERSAPOINT ELECTRODE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code HIH·October 25, 2019

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021