BEUDAMED
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    SCARF THREAD-HEAD SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074524702·SPACER 2962236 CAPSTONEL PEK VBSEND36X12

    Sklar

    FDA UDI
    SKLAR CORPORATION·50649111439757·VIENNA NSL SPEC MD STRL CS/25

    DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ax Stand-Alone ALIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 3, 2015

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 14, 2013

    COULTER ACT DIFF 2 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 28, 2014

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code EPY·December 3, 2024