BEUDAMED
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    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0600110·Tray Insert, ISP, Implant

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0600110·Tray Insert, Lumbar Instruments, 3

    MIIG SR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CS 7600 Smart Plate

    FDA UDI
    CARESTREAM HEALTH, INC.·40889971060019·CS7600 SMART PLATE SIZE 4 V2 - 2 PCS

    n/a

    FDA UDI
    Ortho Development Corporation·00822409074648·12/14 Centralizer Trial 11mm

    Encompass Hip Stem

    FDA UDI
    Ortho Development Corporation·00822409011865·11mm Distal Centralizer

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037312131·K-WIRE GUIDE WITHOUT GAUGE

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193104201·HA PEEK EVOS Curved, , 11mmx11mmx 26mm , FLAT 6...

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·June 20, 2022

    TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODIFIED HYDROPHILIC COATED GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)

    Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

    FDA Enforcement
    Class II ·Terminated·Handicare AB·October 18, 2017

    TOTAL ASR FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·April 16, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATION CENTER-SILICON VALLEY·Product code GEX·March 14, 2011

    LADARVISION 4000

    FDA Adverse Event
    Malfunction ·ALCON - ORLANDO TECHNOLOGY CENTER·Product code LZS·June 12, 2008

    FDA Pre-Market Approval
    RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES

    FDA Pre-Market Approval
    RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)