FDA.reportPublic FDA data

Becton, DIckinson and Company

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12138091213809Becton, DIckinson and Company1N2026-01-01ROUTE 7 AND GRACE WAY CANAAN CT US 06018
30080074723008007472Becton, Dickinson and Company1N2026-01-011022 CORPORATE PARK DRIVE Mebane NC US 27302
30329166323032916632BECTON, DICKINSON AND COMPANY1Y2026-01-0117200 Laguna Canyon Rd Irvine CA US 92618

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00382906718167Horizon - BD Horizon™ CD19 (SJ25C1) RB613+1(877)232-8995BDBCustomerService@bd.com
00382906718174Horizon - BD Horizon™ CD10 (HI10a) RB780+1(877)232-8995BDBCustomerService@bd.com
00382906718181Horizon - BD Horizon™ CD10 (HI10a) R718+1(877)232-8995BDBCustomerService@bd.com
00382906718198Horizon - BD Horizon™ CD107a (H4A3) V450+1(877)232-8995BDBCustomerService@bd.com
00382906718204Horizon - BD Horizon™ CD138 (MI15) R718+1(877)232-8995BDBCustomerService@bd.com
00382906718211Horizon - BD Horizon™ CD14 (MfP9) RB613+1(877)232-8995BDBCustomerService@bd.com
00382906718235Horizon - BD Horizon™ CD16 (3G8) R718+1(877)232-8995BDBCustomerService@bd.com
00382906718242Horizon - BD Horizon™ CD16 (3G8) RB613+1(877)232-8995BDBCustomerService@bd.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1090281367663964P970018BD PREPSTAIN SYSTEMMKQ1999-06-17
275642068919674K992734BECTON DICKINSON SYRINGEMEG1999-10-01
3394401624623896K983802LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SBMJN1999-07-30
275641459435978K980987BECTON DICKINSON SYRINGEFMF1998-06-11
275641121598424K980580BECTON DICKINSON SYRINGESFMF1998-06-25
275642035939117K974363BECTON DICKINSON BLUNT PLASTIC CANNULAFMI1998-06-03
275641713792899K974006BECTON DICKINSON TWINPAKFMI1998-01-22
3394401402540327K951566SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]DYG1995-11-27
275641410905779K951254SAFETYGLIDE NEEDLEFMI1995-10-07
275641326736560K944757PISTON SYRINGESFMI1995-01-11
3394401849442333K942457GRAFT THROMBECTOMY INSTRUMENTSMCW1995-02-07
275641305998968K9415621ML LUER-LOK SYRINGEFMF1994-05-26
3394401230174822K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETERDYG1994-05-24
275641026307884K940697BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCKFPA1994-08-30
3394401276395751K934742SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORTDYG1994-01-24
3394401802546451K926450EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATHDQE1993-02-22
3394401301038450K925638PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600DXO1993-10-18
3394401760674244K924661SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETERKRA1993-04-08
3394401113427413K924452SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETERDYG1993-10-29
275641509842408K924439BECTON DICKINSON INTERLINK VIAL ACCESS CANNULAFMI1993-02-12
275641954536149K924072BECTON DICKINSON SAFETY-LOK SYRINGEFMF1992-12-17
3394402073667714K915726PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATHDQO1992-09-21
3394401097746347K910204SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)DQO1991-04-24
3394401748949150K905707BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERSFGE1991-02-13
3394401177215850K905458SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHERDQE1991-02-07
3394402031753840K901736OXIMETRY PROBE CATHETERSDQE1990-09-11
3394401584598161K901625FOGARTY ARTERIAL EMBOLECTOMY II CATHETERDXE1990-07-06
3394401734450555K896819VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONKRA1990-01-19
3394401773021761K896466SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUMEDYG1990-02-08
3394401068978934K892410FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETERDXE1989-07-20
3394401216484974K864330SHEAR FORCE GAUGEDXE1987-01-06
3394401904290553K832554FOGARTY 6MM SOFTJAW CLIPDXC1983-09-29
3394401468888625K822723SWAN-GANZ BIPOLAR PACING CATHETERDYG1982-10-15
3394401509749320K822350SWAN-GANZ FLOW-DIRECTED THERMODIL. CATHDYG1982-08-24
3394401473786671K821416DISPOSABLE BLOOD PRESSURE TRANSDUCERDRS1982-07-02
3394401189017095K820222SWAN-GANZ VIP-CATHETERDYG1982-02-12
3394401894594523K813521TRANSLUMINAL BIPOLAR PACING PROBELDF1982-03-15
3394401165348493K812563SWAN-GANZ & EDSLAB HEPARIN COATED CATH.DYG1981-09-25
3394401361762553K811411SWAN-GANZ HEPARIN COATED, ETC. CATHETERKRB1981-06-12
3394401703298987K811399EDSLAB CLOSED INJECTATE DELIVERY SYSTEMKRB1981-06-09
3394401990791780K810352SWAN-GANZ FLOW-DIRECTED THERMODILUTIONDYG1981-03-27
3394401130553587K810162FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06DXC1981-02-04
3394401735338808K810124SWAN-GANZ VIP THERMODILUTION CATHETERDYG1981-02-04
3394401414520258K803058SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.LDF1981-01-16
275641666781958K801343B-D FILTER NEEDLEFPB1980-06-20
3394401204896052K791183SWAN-GANZ FLOW-DIRECTED CATHETERLDF1979-07-12
3394401480140132K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC2026-06-05
3394401038748636K253186HemoSphere Nano Monitor (HSNANO1)DQK2026-02-24
3394401551645930K253034HemoSphere Stream ModuleDQK2025-10-21
3394401312740283K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)DQK2025-12-18
3394401732095306K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)DQK2025-07-23
3394401668444905K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsDRS2025-03-21
3394401107626168K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)DYG2024-12-09
3394401410580993K241330Fogarty Fortis Arterial Embolectomy CatheterDXE2024-07-02
3394401706424413K240078Fogarty Thru-Lumen Embolectomy CatheterDXE2024-08-28
3394402042826232K233984Acumen Assisted Fluid Management (AFM) Software FeatureQMS2024-08-02
3394401841495761K233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)DYG2024-06-27
3394401568545864K233824Swan-Ganz catheterDYG2024-06-06
3394401770570868K233820Fogarty Arterial Embolectomy Catheter with Gate ValveDXE2024-05-22
3394401483808450K233819Fogarty Venous Thrombectomy CathetersDXE2024-05-22
3394401143591033K233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersDXE2024-05-20
3394401792942879K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One)DQK2023-10-31
3394401668237925K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformDYG2023-09-21
3394401249083115K231035FusedCO AlgorithmDQK2023-07-12
3394401561685201K230919Acumen IQ finger cuffDXN2023-10-24
3394401174458396K230612Edwards Algorithm for Measurement of Blood HemoglobinMUD2023-11-17
3394401341439408K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference SensorDQK2023-06-09
3394401181996883K222216TruWave Disposable Pressure TransducerDXO2022-12-22
3394401337307380K222117Swang-Ganz IQ pulmonary artery catheterDYG2022-12-09
3394401092704160K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder RemoteDQK2022-06-22
3394401681462949K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction IndexDQK2021-05-28
3394401740655559K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformDXN2021-01-22
3394401218327303K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleDQK2020-10-01
3394401034676479K193466Swan-Ganz CathetersDYG2020-02-16
3394401079416708K193379Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeDXE2020-06-12
275641188430539K192538BD Syringe NRFit Lok and BD Syringe NRFit SlipQEH2020-09-04
3394401166128315K191089Edwards Pressure CableDQK2019-06-13
3394401153726771K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleDQK2019-08-29
3394401288548638K190130The ClearSight finger cuffsDXN2019-06-21
3394401515512500K183413TruWave Disposable Pressure TransducerDXO2019-05-01
3394401047238689K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight SystemDXN2018-11-30
3394401239872766K181684VAMP Plus Venous/Arterial Blood Management Protection SystemKRA2018-11-08
3394401001906641K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableDQK2018-11-16
3394401476302913K180275VAMP Optima closed blood sampling systemKRA2018-10-24
3394402047750814K180003FORE-SIGHT ELITE Module Tissue OximeterMUD2018-05-10
3394401903454770K173586VAMP Venous/Arterial Blood Management Protection SystemKRA2018-04-05
3394401311679955K172660Duravess bovine pericardial vascular patchPSQ2017-11-17
3394401199837785K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)DQE2018-02-20
3394401796594848K171996TruWave Disposable Pressure TransducerDXO2017-10-23
3394401177354741K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableDQK2017-04-14
275641742512149K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeFMF2016-12-19
3394401249883362K161962VAMP Venous/Arterial Blood Management Protection SystemKRA2016-11-28
3394401886550076K160645PreSep Oligon Oximetry CatheterDQE2016-06-16
3394401342083942K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformDXN2016-06-01
3394401617448850K160084Swan Ganz CathetersDYG2016-05-03
3394402072411171K152980Flo Trac sensor, Volume View sensorDRS2016-01-19
3394401349384422K152762Fogarty Occlusion CatheterMJN2015-11-23
3394401662191292K152633Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing ProbeLDF2015-10-15
3394401796990708K143675FORE-SIGHT Elite Absolute Tissue OximeterMUD2015-04-10
3394401809045048K142749TruWave Disposable Pressure TransducerDXO2015-01-18
3394401814657590K141495TRUWAVE DISPOSABLE PRESSURE TRANSDUCERDXO2014-09-03
3394401775259275K140312EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEMDXN2014-06-13
3394401706997750K131892EV1000 CLINICAL PLATFORMDXG2014-05-22
3394401135121108K131588VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITORDXG2014-05-22
275641366874440K112434BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTIONKNT2011-09-29
275642002288497K110771BD SINGLE USE, HYPODERMIC SYRINGEFMF2011-05-13
3394401608585947K110167PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)DQE2011-02-18
3394401761273198K100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5KRB2010-12-07
3394401904624959K093911FOGARTY OCCLUSION CATHETERMJN2010-01-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYG192024-12-09
DQK142026-02-24
FMF132016-12-19
DXE92024-08-28
FMI91998-06-03
DQE82018-02-20
DXN62023-10-24
DXO62022-12-22
KRA62018-11-08
LDF42015-10-15
DXC32026-06-05
DRS32025-03-21
MUD32023-11-17
MJN32015-11-23
DXG32014-05-22
KRB32010-12-07
DQO32002-03-08
MEG32001-06-13
KNT22011-09-29
LON22005-04-29
DYB22003-06-20
FPA22001-06-19
QMS12024-08-02
QEH12020-09-04
PSQ12017-11-17
FOZ12003-12-30
DQY12003-10-02
MKQ11999-06-17
MCW11995-02-07
FGE11991-02-13
FPB11980-06-20

PMA#

PMN#

107 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next