BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EDWARDS LIFESCIENCES TECHNOLOGY SARL

    Reg #: 2648045 · FEI: 2648045 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    88
    Establishment Types
    2
    Classifications
    28

    Registration Details

    Registration Name
    EDWARDS LIFESCIENCES TECHNOLOGY SARL
    Registration Number
    2648045
    FEI Number
    2648045
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    STATE ROAD 402, KM 1.4, Industrial Park
    City
    ANASCO
    State
    PR
    ZIP
    00610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233819

    Owner / Operator

    Firm Name
    Becton, Dickinson and Company
    Operator Number
    10093301
    Address
    17200 Laguna Canyon Road
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Karen M O'Leary

    Products

    Device Name Product Code
    Catheter, Embolectomy DXE
    Catheter, Flow Directed DYG
    Catheter, Oximeter, Fiber-Optic DQE
    Introducer, Catheter DYB
    Catheter, Peripheral, Atherectomy MCW
    Probe, Thermodilution KRB
    Electrode, Pacemaker, Temporary LDF
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Clamp, Vascular DXC
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Catheter, Continuous Flush KRA
    Transducer, Blood-Pressure, Extravascular DRS
    Catheter, Intravascular Occluding, Temporary MJN
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Transducer, Pressure, Catheter Tip DXO
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Plethysmograph, Impedance DSB
    Adjunctive Predictive Cardiovascular Indicator QAQ
    Computer, Diagnostic, Programmable DQK
    Clamp, Surgical, General & Plastic Surgery GDJ
    Catheter, Irrigation GBX
    Oximeter, Tissue Saturation MUD
    Adjunctive Open Loop Fluid Therapy Recommender QMS
    Continuous Measurement Thermometer FLL
    Catheter, Percutaneous DQY

    Proprietary Names

    Fogarty Venous Thrombectomy Catheter SWAN-GANZ SWAN-GANZ Thermodilution Catheter, VIP and VIP+, True Size PreSep INTRO-FLEX Introducer Fogarty AVA HF Chandler Transluminal V-Pacing Prove- D98100/670923010 Chandler Transluminal V-Pacing Prove- D98500/670924010 Flex-Tip Tranluminal A-Pacing Probe- D98100/670923010 Flex-Tip Tranluminal A-Pacing Probe- D98500/670924010 SWAN-GANZ Polymer Blend True Size ControlCath Thermodilution Catheters Swan-Ganz COO/SVO2 SWAN-GANZ Continuous Cardiac Output Thermodilution Catheter SWAN-GANZ Right Heart Ejection Fraction Thermodilution and Oximetry Catheter Double Lumen Oximetry Catheter Swan-Ganz HI-SHORE Vantex Multi Med PediaSat Oximetry Catheter Swan Ganz Catheters Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts VolumeView Multi-Med PreSep Oximetry Catheters Edwards Oximetry Central Venous Catheter Fogarty Graft Thrombectomy Catheter Fogarty Corkscrew Catheter Swan-Ganz Catheters VASCULAR CLAMP Fogarty 6mm Spring Clip VolumeView sensor FloTrac Sensor FloTrac Jr Sensor Acumen IQ sensor Fogarty Occlusion Catheter SWAN-GANZ Continuous Cardiac Output/End Diastolic Volume Thermodilution Catheter Fogarty Arterial Embolectomy Catheter Fogarty Biliary Balloon Probe Swan-Ganz Pacing-TD Catheter Swan-Ganz Bipolar Pacing Catheter CO-SET Thru-lumen Embolectomy catheter Laparoscopic Cholangiography Catheter EOCVC Kit Edwards Oximetry Central Venous Catheter Kit Fogarty Fortis Arterial Embolectomy Catheter TruWave Disposable Pressure Transducer Transducers Pressure Monitoring Kit with TruWave Disposable Pressure Swan IQ Pulmonary Arterial Catheter Swan-Ganz IQ catheter - AIQSGF8 FloTrac Jr sensor ClearSight Jr finger cuff Swan-Ganz Jr catheter HemoSphere Shear Force Gauge PACEMAKER TEMPORARY ELECTRODE Fogarty Softjaw Spring Clip Swan-Ganz Continuous Cardia Output Thermodilution Catheter Swan-Ganz Thermodilution Catheter Swan-Ganz Oximetry Catheter Percutaneous Sheath Introducers Fogarty Arterial Embolectomy Catheter with Gate Valve HemoSphere Vita Monitor Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter HemoSphere Technology Module Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter, 5-pack HemoSphere Advanced Monitor ViewFinder Remote Acumen IQ sensor with 84” (213cm) pressure tubing, Acumen IQ fluid meter, 5-pack HemoSphere Vita Technology Module HemoSphere Pressure Cable Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult Pressure Controller Kit Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult, 5-pack HemoSphere Oximetry Cable HemoSphere ClearSight Module HemoSphere Swan-Ganz Module Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult with TruWave DPT, 5-pack HemoSphere ForeSight Oximeter Cable Acumen AFM Cable Heart Reference Sensor HemoSphere VitaWave Module Acumen IQ sensor with 84” (213cm) pressure tubing with Acumen IQ fluid meter Acumen IQ Fluid Meter Edwards Peripheral Dilation Catheter Swan-Ganz

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)