FDA.reportPublic FDA data

BD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
19208981920898BD MEDICAL1N2026-01-011329 West Highway 6 Suite A HOLDREGE NE US 68949
26182822649711BD Puerto Rico LLC1N2026-01-01RD 31, KM 24.3 Juncos PR US 00777
30093441793009344179BDK INDUSTRIAL PRODUCTS LTD1N2026-01-01Levington Park, Bridge Road Levington Ipswich Suffolk GB IP10 0JE
30114813503011481350BD MEDICAL DEVELOPMENT1N2026-01-011140 Millennium Dr Crown Point IN US 46307
30130554893013055489BD European Distribution Center1N2026-01-01Laagstraat 57 Temse Oost-Vlaanderen BE B-9140
30364951713036495171BD Biosciences San Diego1N2026-01-0111214 El Camino Real San Diego CA US 92130
00BDN TRADE, LLC5N2020-04-2516192 Coastal Highway Lewes DE US 19958
30097099093009709909BD&S MEDICAL-DENTAL SUPPLIES INC1Y2020-04-253 Dutch Ct Sinking Spring PA US 19608
30103929883010392988BD1N2020-04-255859 Farinon Dr Ste 200 San Antonio TX US 78249

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1612181367663964P970018BD PREPSTAIN SYSTEMMKQ1999-06-17
1612181217095890P950009AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEMMNM1995-09-29
1612181452734320K993577CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISCJTN1999-12-01
1612181112460131K993186SYNERCID, 15 UG, BBL SENSI-DISCJTN1999-11-03
1612182068919674K992734BECTON DICKINSON SYRINGEMEG1999-10-01
275801198509898K991702MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578JKA1999-07-28
1612181198509898K991702MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578JKA1999-07-28
1612181370452414K991120VACUTAINER BRAND CTAD TUBE (MULTIPLE)JKA1999-05-19
275801900700945K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLEJKA1999-05-28
1612181900700945K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLEJKA1999-05-28
1612181996452932K984631BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAYLSL1999-11-04
1612181355561016K982541VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608FMI1998-10-28
1612181802923469K981517CEFDINIR, 5 UG, SENSI-DISCJTN1998-06-09
1612182028140746K981342ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAYGKZ1998-06-29
1612181934270842K981013VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBEJKA1998-06-17
1612181459435978K980987BECTON DICKINSON SYRINGEFMF1998-06-11
1612181106511780K980858MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTIONGKZ1998-05-22
1612181581219889K980638ADI SYPHILIS RPR LIQUID CONTROLSGMP1998-07-06
1612181121598424K980580BECTON DICKINSON SYRINGESFMF1998-06-25
1612181845319453K980414VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SETJKA1998-03-03
1612181404882371K980098VACUTAINER BRAND PRONTO NEEDLES HOLDERJKA1998-02-05
1612181427897436K974883BACTEC MGIT 960 SYSTEMMDB1998-05-01
1612182035939117K974363BECTON DICKINSON BLUNT PLASTIC CANNULAFMI1998-06-03
1612181429392381K974083CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKSFMG1998-01-13
1612181713792899K974006BECTON DICKINSON TWINPAKFMI1998-01-22
1612181359494826K973483FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SETGKZ1998-02-17
1612181773621586K972448COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOALJSL1997-08-20
1612181747760278K972098FOSFOMYCIN, 200 MG, SENSI-DISCJTN1997-07-28
1612181589395474K972075VACUTAINER BRAND PPT PLASMA PREPARATION TUBEPJE1998-02-24
1612181153190055K971449VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)GIM1997-06-17
1612181998688778K971205TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-12-01
1612181064288628K971110TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-11-25
1612181384647625K970836TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADSGKZ1997-08-26
1612181806840734K970742TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-10-22
1612182054439127K970385SPARFLOZACIN, 5 MCG, SENSI-DISCJTN1997-03-10
1612181130378748K970326TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-11-21
1612181911457767K970212LEVOFLOXACIN, 5MCG, SENSI-DISCJTN1997-03-06
1612181428533714K963963MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSISGKZ1996-12-12
1612182014342842K963845MEROPENEM, 10 MCG, SENSI-DISCJTN1996-10-25
1612181534815938K963036MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOODJTZ1996-10-07
1612181544581434K961188CEFEPIME, 30 MCG, SENSI-DISCJTN1996-04-05
1612181311258911K960313MUELLER HINTON AGAR WITH 2% NACIJTZ1996-03-25
1612182010311444K960250VACUTAINER BRAND PLUS SERUM & SST TUBESJKA1996-03-29
275771786101750K955235B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGEFMI1996-02-12
1612181351527679K954932BBL MGIT PRODUCTSMDB1996-08-21
1612181020253967K954592VACUTAINER BRAND PST PLASMA SEPARATION TUBEJKA1995-11-28
1612181186297726K953994SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEMJKA1995-09-26
275801811181526K953790BD PERISAFE EPIDURAL ANESTHESIA TRAYCAZ1995-11-30
1612181811181526K953790BD PERISAFE EPIDURAL ANESTHESIA TRAYCAZ1995-11-30
1612181750196610K953302FACS LOADER SYSTEMGKZ1995-11-20
1612181500606851K952861ANGIOCATH & INSYTE AUTOGUARD CATHETERSFOZ1995-07-31
1612181366199563K952791DIRECTIGEN MENINGITIS COMBO TESTGTJ1996-05-30
1612181768996083K951539ENTEROCOCCUS SCREENING MEDIUMJWY1995-06-13
1612181410905779K951254SAFETYGLIDE NEEDLEFMI1995-10-07
1612181883680211K950303DESERET(R) I.V. LOOP AND DESERET (R) J LOOPFPA1995-03-14
1612181423731790K950057TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCPGKZ1995-08-22
1612181594800913K946288COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUMJSM1995-03-10
1612181457934688K946283COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUMJSM1995-03-10
1612182012398865K946055TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCPGKZ1996-02-20
1612181588694454K945952VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBEJKA1995-01-18
1612181622741270K945569GCII AGAR WITH ISOVITALX(R) ENRICHMENTJSO1995-02-02
275771326736560K944757PISTON SYRINGESFMI1995-01-11
1612181326736560K944757PISTON SYRINGESFMI1995-01-11
1612181548978851K944566VACUTAINER BRAND PLUS SODIUM HEPARIN TUBEJKA1994-11-10
1612181753265910K944528BBLCRYSTAL ANAEROBE ID SYSTEMJSP1995-03-07
1612181121228795K943407GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTSJTN1994-10-27
1612181925441403K943141B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORSFMI1994-11-07
1612181213791108K943140B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORSFMI1994-11-07
1612182037895782K943139B-D GUARDIAN ONE PIECE SHARPS COLLECTORSFMI1994-11-28
1612181401400552K943138VACUTAINER BRAND NEEDLE DISPOSAL CONTAINERMMK1994-11-28
1612181103401837K943134B-D GUARDIAN NESTABLE SHARPS COLLECTORSFMI1994-11-07
275771433499772K941657BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGEFMF1994-05-26
1612181305998968K9415621ML LUER-LOK SYRINGEFMF1994-05-26
275801420390202K940905MICROTAINER BRAND TUBE WITH EDTA(K2)JKA1994-08-02
1612181026307884K940697BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCKFPA1994-08-30
1612181455147678K940359PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISCJTN1994-03-01
1612181550916376K933486FASCOUNT SYSTMEGKZ1994-09-09
1612181455706360K933467PRN ADAPTERFOZ1994-12-12
275801344467194K932249DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIACAZ1993-08-27
1612181344467194K932249DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIACAZ1993-08-27
1612181971201489K931374AFFIRM VPIII MICROBIAL IDENTIFICATION TESTMLA1993-06-15
275801083075321K931368MICROTAINER BRAND TUBE WITH EDTAJKA1993-09-28
1612181083075321K931368MICROTAINER BRAND TUBE WITH EDTAJKA1993-09-28
275801224154896K925902B-D LOSS OF RESISTANCE SYRINGECAZ1993-01-14
1612181224154896K925902B-D LOSS OF RESISTANCE SYRINGECAZ1993-01-14
1612181719626455K924797CEFPODOXIME 10 MCG, SENSI DISCJTN1992-11-02
1612181492615083K924587SIMULTEST CD3/ANTI-HLA-DRGKZ1993-08-05
1612181509842408K924439BECTON DICKINSON INTERLINK VIAL ACCESS CANNULAFMI1993-02-12
1612181954536149K924072BECTON DICKINSON SAFETY-LOK SYRINGEFMF1992-12-17
1612181340871564K923952ENOXACIN 10 MCG. SENSI SISCJTN1992-09-18
1612181867469915K923790FACSORT FLOW CYTOMETERGKZ1993-09-01
1612182006535700K923268AFFIRM PROCESSORJQW1992-07-30
1612181682771062K921806VACUTAINER(R) BRAND SST(R) AND CAT TUBESJKA1992-04-29
1612181765050226K921520VACUTAINER BRAND LUER ADAPTERJKA1992-07-10
1612181098465204K921420AZITHROMYCIN, 15 MCG, SENSI DISCJTN1992-05-08
1612181639210925K921193LOMEFLOXACIN, 10 MCG, SENSI DISCJTN1992-04-27
1612182021631449K920536AFFIRM VP SAMPLE COLLECTION SETLIO1992-07-30
1612181033691029K920473CEFPROZIL 30MCG, SENSI DISCJTN1992-03-23
1612181007679150K920422B-D INTERLINK SYRINGE CANNULAFMF1992-04-29
1612181001118975K920274DIRECTIGEN NEISSERIA MENINGITIDIS TESTGTI1992-03-18
1612181882407078K920131CLARITHROMYCIN 15MCG SENSI DISCJTN1992-02-06
275801205520060K915480B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.DWD1992-01-07
1612181205520060K915480B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.DWD1992-01-07
1612181967909349K913192SIMULTEST(TM) IMK-LYMPHOCYTEGKZ1992-02-06
1612181167351692K911731LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITRJCF1992-12-15
1612181807423128K910506OFLOXACIN, 5 MCG SENSI-DISCJTN1991-03-04
1612181722322524K904390ANTI-HUMAN LEU-2A (CD8) PEGKZ1990-12-17
1612181958890038K903425HAEMOPHILUS TEST MEDIUM (HTM) BROTHJSO1990-08-22
1612181168915062K901449VACUTAINER PLUS WITH HEMOGARD CLOSUREJKA1990-08-09
1612181070672126K901360LEVEEN PERITINEO-VENOUS SHUNTKPM1990-08-21
1612181476606197K900802ANTI-HUMAN LEU-3A (CD4) FITCGKZ1990-05-15
1612181625036503K900078SIMULTEST IMK PLUS(TM)GKZ1990-04-02
1612181422358531K895679CEFMATZOLE 30 MCG SENSI DISCJTN1990-01-02
1612181985373283K894216HAEMOPHILUS TEST MEDIUM (HTM)AGARJSO1989-12-13
1612181023994374K893754CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DISJTN1989-07-14
1612181056411387K891772SPECTINOMYCIN 100 MCG SENSI-DISCJTN1989-08-21
1612181884658088K891719TRU-TOUCH VINYL, NON-STERILELYZ1989-12-05
1612181700710880K891407LEUCOPREP CELL SEPARATION TUBEJCF1989-05-26
1612181368570363K884623SAFE-TEC CAPILLARY BLOOD COLLECTION TUBEGIO1988-12-01
275801835139217K881697BREAST LESION LOCALIZATION NEEDLEIZH1988-09-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LON1082009-01-29
JTN582011-10-18
JKA342026-04-10
FMI282018-12-20
GKZ262009-07-31
PSZ152018-03-20
FMF142019-10-21
CAZ112022-05-19
FOZ112020-01-24
FPA72016-04-07
LSL72009-11-13
BSP62022-07-01
GQG42013-11-15
MDB42013-05-13
JSO42010-08-20
JSM42004-12-07
JTZ41996-10-07
ONB32025-09-12
NGT32017-02-02
GTY32013-02-06
MKZ32009-11-13
MJA32002-07-13
MEG32001-06-13
JTY31987-02-03
GIM22023-11-27
OYE22017-07-03
PER22013-08-02
NJR22012-02-16
LHI22009-12-07
NTW22005-04-18
SCL22003-09-09
JQW22003-06-24
GTJ21996-05-30
JCF21992-12-15
DWD21992-01-07
IZH21988-09-14
KNE21988-06-01
GKL21988-03-21
BSO21985-03-11
JTW21984-09-27

NDC#

PMA#

BD FocalPoint GS Imaging System

2022-07-11

BD DIAGNOSTICS4025 Stirrup Creek Drivesuite 400durham, NC 27703 PMA NumberP950009 Supplement NumberS026 Date Received06/15/2022 Decision Date07/11/2022 Product Code MNM  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Cha...

88 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

Applications#