BEUDAMED
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    BLUE FIELD ENTOPTOSCOPE BFE100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199120·AK3 Congruent Insert Trial Size 5, 10mm

    LOQTEQ®

    FDA UDI
    aap Implantate AG·04042409234217·Direct measuring device LOQTEQ, green, for K-wi...

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae

    FDA 510(k)
    FDA Class 2 ·Immunology

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    M2A-MAGNUM MOD HD SZ 46MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 16, 2018

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 16, 2018

    SPECIAL DEVICE UNITIZED PROGRA

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·November 29, 2023

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 5, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 15, 2012

    FR2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS, HEARTSTREAM·Product code MKJ·August 6, 2010

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018