BEUDAMED
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    SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756981408·KIDNEY LIVER PACK PGYBK

    Carnation Ambulatory Monitor (CAM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FX 222-02 POWERED WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·July 21, 2011

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·December 8, 2010

    TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·May 31, 2019

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 11, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIAN) PRIVATE LTD·Product code JAA·November 10, 2010

    CUSTOM PAK

    FDA Adverse Event
    Malfunction ·ALCON - HOUSTON·Product code KYG·February 25, 2014

    DRB1 SSP UNITRAY KIT WITH TAQ POLYMERASE

    FDA Adverse Event
    Malfunction ·LIFE TECHNOLOGIES CORPORATION·Product code MZI·January 23, 2014

    WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 29, 2017

    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·November 24, 2021

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021

    Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024