BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BECTON, DICKINSON AND COMPANY

    Reg #: 3032916632 · FEI: 3032916632 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    183
    Establishment Types
    2
    Classifications
    35

    Registration Details

    Registration Name
    BECTON, DICKINSON AND COMPANY
    Registration Number
    3032916632
    FEI Number
    3032916632
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    17200 Laguna Canyon Rd
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K905707

    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
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Recorder, Paper Chart DSF
    Catheter, Flow Directed DYG
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Catheter, Oximeter, Fiber-Optic DQE
    Computer, Diagnostic, Programmable DQK
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Catheter, Intravascular Occluding, Temporary MJN
    Catheter, Embolectomy DXE
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Continuous Flush KRA
    Transducer, Blood-Pressure, Extravascular DRS
    Probe, Thermodilution KRB
    Plethysmograph, Impedance DSB
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Transducer, Pressure, Catheter Tip DXO
    Catheter, Percutaneous DQY
    Adjunctive Predictive Cardiovascular Indicator QAQ
    Oximeter, Tissue Saturation MUD
    Adjunctive Open Loop Fluid Therapy Recommender QMS
    Continuous Measurement Thermometer FLL
    Medium-Term Adjunctive Predictive Cardiovascular Indicator QNL
    Cerebral Oximeter QEM
    Electrode, Pacemaker, Temporary LDF
    Stand, Infusion FOX
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Clamp, Vascular DXC
    Catheter, Peripheral, Atherectomy MCW
    Intracardiac Patch Or Pledget, Biologically Derived PSQ
    Introducer, Catheter DYB
    Stopcock, I.V. Set FMG
    Set, Administration, Intravascular FPA
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Clamp, Surgical, General & Plastic Surgery GDJ
    Catheter, Irrigation GBX

    Proprietary Names

    Laparoscopic Cholangiography Catheter EDWARDS CRITICAL-CARE SWAN-GANZ Thermodilution Catheter, VIP and VIP+, True Size EOCVC Kit Edwards Oximetry Central Venous Catheter Kit HemoSphere Pressure Cable HemoSphere ClearSight Module VitaWave Plus finger cuff HemoSphere Vita Monitor HemoSphere Technology Module HemoSphere Vita Technology Module Acumen IQ Plus Finger Cuff HemoSphere Advanced Monitor Smart Pressure Controller HemoSphere VitaWave module HemoSphere Nano Monitor Edwards Vascushunt II SWAN-GANZ Fogarty VAMP Venous/Arterial Blood Management Protection System DISPOSABLE PRESSURE DOME Dome Swan-Ganz Catheters VolumeView ClearSight finger cuff HemoSphere Advanced Monitor (HEM1) HemoSphere Swan-Ganz Module (HEMSGM10) HemoSphere Oximetry Cable (HEMOXSC100) TruWave Disposable Pressure Transducer PreSep Edwards Peripheral Dilation Catheter Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter, 5-pack ViewFinder Remote Acumen IQ sensor with 84” (213cm) pressure tubing, Acumen IQ fluid meter, 5-pack 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 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 Acumen Hypotension Prediction Index Acumen Assisted Fluid Management Viewfinder Remote VAMP Plus Venous/Arterial Blood Management Protection System Fogarty Venous Thrombectomy Catheter Thru-lumen Embolectomy catheter HemoSphere Tissue Oximetry Module FORE-SIGHT ELITE PRE-AMP CABLE 4m and 6.5m FORE-SIGHT ELITE TISSUE OXIMETER SENSORS, ForeSight Sensors FORE-SIGHT ELITE Tissue Oximeter Acumen Hypotension Prediction Index Feature HemoSphere Pressure-Out Cable (HEMDPT1000) Disposable Pressure Transducer TruWave™ Disposable Pressure Transducers Disposable Pressure Transducer ClearSight and AcumenIQ finger cuffs HemoSphere AltaTM advanced monitor (Smart Recovery) HemoSphere AltaTM advanced monitor (Cardiac) HemoSphere AltaTM advanced monitor (All-on-One) SWAN-GANZ Continuous Cardiac Output Thermodilution Catheter Swan-Ganz Thermodilution Catheter Pressure Controller EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Cuffs or ClearSight System EV1000 Clinical Platform Fogarty Occlusion Catheter Acumen IQ finger cuff Acumen IQ finger cuff adult VitaWave finger cuff adult Swan-Ganz Pacing-TD Catheter Swan-Ganz Bipolar Pacing Catheter BD Algorithm for Measurement of Blood Hemoglobin Total Blood Hemoglobin (tHb) Algorithm FloTrac Sensor FloTrac Jr Sensor Transducer, blood-pressure, extravascular VolumeView sensor Acumen IQ sensor Swan-Ganz TruClip Swan-Ganz COO/SVO2 Shear Force Gauge Swan IQ Pulmonary Arterial Catheter Swan-Ganz IQ catheter - AIQSGF8 FloTrac Jr sensor ClearSight Jr finger cuff Swan-Ganz Jr catheter HemoSphere Swan Ganz Catheters SWAN-GANZ Polymer Blend True Size ControlCath Thermodilution Catheters Swan-Ganz Oximetry Catheter VASCULAR CLAMP Fogarty 6mm Spring Clip HemoSphere Alta Advanced Monitoring Platform Patient CCO cable - HemoSphere Alta advanced monitoring platform PACEMAKER TEMPORARY ELECTRODE MHM1E MHM1 Vigileo Monitor TruWave Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts Fogarty Arterial Embolectomy Catheter Fogarty Biliary Balloon Probe Fogarty Arterial Embolectomy Catheter with Gate Valve FusedCO Algorithm Duravess SWAN-GANZ Continuous Cardiac Output/End Diastolic Volume Thermodilution Catheter Percutaneous Sheath Introducers PreSep Oximetry Catheters Edwards Oximetry Central Venous Catheter PediaSat Oximetry Catheter PX 1800 TRUCLIP CATHETER TIP, PRESSURE TRANSDUCER Accumen IQ finger cuff EV1000 Clinical Platform NI EV1000NI Clearsight EV1000 Non-invasive Clearsight system Clearsight finger cuff SWAN-GANZ Right Heart Ejection Fraction Thermodilution and Oximetry Catheter Swan-Ganz Continuous Cardia Output Thermodilution Catheter EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System VAMP Optima closed blood sampling system HemoSphere ClearSIght Module EV1000 EV1000M EV1000DB EV1000A Double Lumen Oximetry Catheter Fogarty Fortis Arterial Embolectomy Catheter Acumen Assisted Fluid Management (AFM) Software Feature AFM Feature with AFM Prompt Reclassifier algorithm (AFM PR algorithm) CO-SET Transducers Pressure Monitoring Kit with TruWave Disposable Pressure Fogarty Graft Thrombectomy Catheter Fogarty Corkscrew Catheter VAMP VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION TruWave™ Disposable Pressure Transducers Vantex INTRO-FLEX Introducer Vigilance II HemoSphere Alta Advanced Monitor HemoSphere Alta - Monitor Pressure Cable Acumen AFM cable - HemoSphere Alta monitor ForeSight IQ Sensor FloTrac Pressure Cable Flo Trac Pressure Cable - BeneVision FloTrac Pressure Cable-Philips Parallel Jaw Spring Clamp EverGrip Insert Handleless Clamp Fogarty-Hydragrip Surg Clamp Insert Swan-Ganz HI-SHORE 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 HemoSphere Stream Module FORE-SIGHT ELITE MODULE TISSUE OXIMETER FORE-SIGHT ELITE MODULES Fogarty Softjaw Spring Clip Flotrac Sensor-MHD6AZ Flotrac Sensor-MHD6AZ5 Flotrac Sensor-MHD6AZA VolumeView Sensor-VLV8R5 Flotrac Sensor-MHD8S102 Flotrac Sensor-MHD6AZ VolumeView Sensor-VLV6R5 Flotrac Sensor-MHD6C502 Acumen IQ Sensor Flotrac Sensor-MHD8 Flotrac Sensor-MHD65 Flotrac Sensor-MHD6 Flotrac Sensor-MHD8 Flotrac Sensor-MHD85 Flotrac Sensor-MHD8C503

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device