BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    GEL-FILLED MAMMARY PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN HEYER-SCHULTE·Product code FTR·April 17, 1998

    BETHENNY EYEWEAR

    FDA UDI
    FGX INTERNATIONAL INC.·00193033475799·

    BETHENNY EYEWEAR

    FDA UDI
    FGX INTERNATIONAL INC.·00193033475805·

    BETHENNY EYEWEAR

    FDA UDI
    FGX INTERNATIONAL INC.·00193033475812·

    BETHENNY EYEWEAR

    FDA UDI
    FGX INTERNATIONAL INC.·00193033475690·

    BETHENNY EYEWEAR

    FDA UDI
    FGX INTERNATIONAL INC.·00193033475782·

    BETHENNY EYEWEAR

    FDA UDI
    FGX INTERNATIONAL INC.·00193033475836·

    BETHENNY EYEWEAR

    FDA UDI
    FGX INTERNATIONAL INC.·00193033475829·

    ENDOCARE PERCUTANEOUS ACCESS SET

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

    COLLAGEN PERIODONTAL MEMBRANE

    FDA 510(k)
    FDA Class 2 ·Dental

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 20, 2013

    COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 10, 2011

    11.0MM TI HELICAL BLADE 105MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HRS·March 13, 2008

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·October 14, 2010

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·March 26, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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