BEUDAMED
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    ULNAR HEAD IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890107860·Zirlux Multi-Unit Abutment 3 mmH compatible wit...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450265741·

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450023624·

    Truliant

    FDA UDI
    Exactech, Inc.·10885862650467·Special LBS III Femoral Paddle Extension, Right

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033238042·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033238066·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033238073·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033238059·

    REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG

    FDA 510(k)
    FDA Class 2 ·Dental

    PEN NDL 32G 4MM PRO 100 BOX FR

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·June 30, 2025

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

    FINNED 1 PIECE TIBIAL TRAY

    FDA Adverse Event
    Injury ·BIOMET SPAIN S.L.·Product code JWH·March 2, 2011

    RIATA ST ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    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 Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012