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Medical device manufacturer

Becton, Dickinson and Company

Becton, Dickinson and Company holds 332 FDA 510(k) clearances across 53 product codes. Median elapsed review time is 68 days. openFDA lists 525 recall records naming the company. FDA publishes it under 18 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
332
Product codes
53
Median review
68 days
Recall records
525

How does FDA spell Becton, Dickinson and Company?

FDA publishes this company under 18 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
BECTON DICKINSON AND COMPANYdevice/registrationlistingnormalised
BECTON, DICKINSON & CO.device/registrationlistingnormalised
BECTON, DICKINSON AND CO.device/registrationlistingnormalised
BECTON, DICKINSON AND COMPANYdevice/registrationlistingnormalised
Becton Dickinson & Codevice/recallnormalised
Becton Dickinson & Co.device/recallnormalised
Becton Dickinson & Co.device/enforcementnormalised
Becton Dickinson & Companydevice/510knormalised

Showing 8 of 18.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Becton, Dickinson and Company file in?

53 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation12250 days
JKATubes, Vials, Systems, Serum Separators, Blood Collection26115 days
FMINeedle, Hypodermic, Single Lumen2269 days
FMFSyringe, Piston1864 days
PSZDevices Detecting Influenza A, B, And C Virus Antigens1827 days
JTNSusceptibility Test Discs, Antimicrobial1140 days
MDBSystem, Blood Culturing9145 days
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days836 days
LSLDna-Reagents, Neisseria862 days
NGTSaline, Vascular Access Flush6123 days
ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System686 days
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus593 days
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System5203 days
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)4265 days
FPASet, Administration, Intravascular430 days
MKZDna Probe, Nucleic Acid Amplification, Chlamydia488 days
GIMTubes, Vacuum Sample, With Anticoagulant3277 days
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days369 days
NBWSystem, Test, Blood Glucose, Over The Counter371 days
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test System3200 days
PCIGastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System3210 days
HMYKeratome, Battery-Powered230 days
JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar241 days
MJASusceptibility Test Powders, Antimycobacterial260 days
NZWHeparin, Vascular Access Flush269 days

Showing the 25 they file in most, of 53.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Becton, Dickinson and Company had a recall?

openFDA lists 525 recall records naming this company across its whole history, of which 24 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

  • Z-2248-2026Class IOpen, ClassifiedCAZ

    This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

  • Z-2249-2026Class IOpen, ClassifiedCAZ

    This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

  • Z-2250-2026Class IOpen, ClassifiedCAZ

    This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

  • Z-2251-2026Class IOpen, ClassifiedCAZ

    This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

  • Z-2252-2026Class IOpen, ClassifiedCAZ

    This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Showing the 5 most recently initiated of 525.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Becton, Dickinson and Company cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesJKA89
K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderJKA245
K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeJKA254
K260184Onclarity™ Self-Collection KitSEP71
K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesJKA256
K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeNGT253
K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR SystemPCI266
K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)ONB245
K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)LON66
K251350BD Plastipak™ SyringeFMF90

Source: openFDA device/510k · retrieved

Where is Becton, Dickinson and Company registered?

FDA lists 9 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.