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.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| BECTON DICKINSON AND COMPANY | device/registrationlisting | normalised |
| BECTON, DICKINSON & CO. | device/registrationlisting | normalised |
| BECTON, DICKINSON AND CO. | device/registrationlisting | normalised |
| BECTON, DICKINSON AND COMPANY | device/registrationlisting | normalised |
| Becton Dickinson & Co | device/recall | normalised |
| Becton Dickinson & Co. | device/recall | normalised |
| Becton Dickinson & Co. | device/enforcement | normalised |
| Becton Dickinson & Company | device/510k | normalised |
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.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 122 | 50 days | |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 26 | 115 days | |
| FMI | Needle, Hypodermic, Single Lumen | 22 | 69 days | |
| FMF | Syringe, Piston | 18 | 64 days | |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 18 | 27 days | |
| JTN | Susceptibility Test Discs, Antimicrobial | 11 | 40 days | |
| MDB | System, Blood Culturing | 9 | 145 days | |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 8 | 36 days | |
| LSL | Dna-Reagents, Neisseria | 8 | 62 days | |
| NGT | Saline, Vascular Access Flush | 6 | 123 days | |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 6 | 86 days | |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 5 | 93 days | |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 5 | 203 days | |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 4 | 265 days | |
| FPA | Set, Administration, Intravascular | 4 | 30 days | |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | 4 | 88 days | |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 3 | 277 days | |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 3 | 69 days | |
| NBW | System, Test, Blood Glucose, Over The Counter | 3 | 71 days | |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | 3 | 200 days | |
| PCI | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System | 3 | 210 days | |
| HMY | Keratome, Battery-Powered | 2 | 30 days | |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 2 | 41 days | |
| MJA | Susceptibility Test Powders, Antimycobacterial | 2 | 60 days | |
| NZW | Heparin, Vascular Access Flush | 2 | 69 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?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K260128 | BD Preset and BD A-Line Arterial Blood Collection Syringes | JKA | 89 | |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | JKA | 245 | |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | JKA | 254 | |
| K260184 | Onclarity Self-Collection Kit | SEP | 71 | |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | JKA | 256 | |
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | NGT | 253 | |
| K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | PCI | 266 | |
| K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | ONB | 245 | |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | LON | 66 | |
| K251350 | BD Plastipak Syringe | FMF | 90 |
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.
Watch what Becton, Dickinson and Company files next
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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.