Company · US
Becton, Dickinson and Company
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2026. Name variants (Inc, Corp, punctuation) are merged.
142510(k) clearances (8 in 12 months)
29recalls (4 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 19 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 15 |
| FMF | Syringe, Piston | 14 |
| FMI | Needle, Hypodermic, Single Lumen | 12 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 12 |
| HNN | Knife, Ophthalmic | 11 |
| HMX | Cannula, Ophthalmic | 7 |
| MDB | System, Blood Culturing | 7 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 6 |
| NGT | Saline, Vascular Access Flush | 5 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 5 |
| JTN | Susceptibility Test Discs, Antimicrobial | 4 |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 4 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 3 |
| FPA | Set, Administration, Intravascular | 3 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 3 |
| PCI | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System | 3 |
| DYG | Catheter, Flow Directed | 2 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 2 |
| HNM | Needle, Ophthalmic Suturing | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K252344 | BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) Becton, Dickinson and Company | JKA |
| Sep 14, 2026 | K262163 | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth Becton Dickinson and Company | JTZ |
| Apr 15, 2026 | K260128 | BD Preset and BD A-Line Arterial Blood Collection Syringes Becton, Dickinson and Company | JKA |
| Apr 10, 2026 | K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holde Becton, Dickinson and Company | JKA |
| Apr 10, 2026 | K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube Becton, Dickinson and Company | JKA |
| Apr 2, 2026 | K260184 | Onclarity Self-Collection Kit Becton, Dickinson and Company | SEP |
| Mar 13, 2026 | K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes Becton, Dickinson and Company | JKA |
| Dec 2, 2025 | K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe Becton, Dickinson and Company | NGT |
| Oct 31, 2025 | K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial P Becton, Dickinson and Company | PCI |
| Sep 12, 2025 | K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) Becton, Dickinson and Company | ONB |
| Aug 8, 2025 | K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) Becton, Dickinson and Company | LON |
| Jul 29, 2025 | K251350 | BD Plastipak Syringe Becton, Dickinson and Company | FMF |
| Jul 3, 2025 | K243207 | BD Vacutainer® Eclipse Blood Collection Needle Becton, Dickinson and Company | JKA |
| Jun 16, 2025 | K243872 | BD Veritor System for SARS-CoV-2 Becton, Dickinson and Company | QVF |
| May 19, 2025 | K250447 | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) Becton, Dickinson and Company | LON |
| Mar 21, 2025 | K243649 | BD Vacutainer® Multiple Sample Luer Adapter Becton, Dickinson and Company | JKA |
| Mar 6, 2025 | K250344 | BD Phoenix Automated Microbiology System Becton, Dickinson and Company | LON |
| Dec 19, 2024 | K243725 | BD Vaginal Panel Becton, Dickinson and Company | PQA |
| Nov 1, 2024 | K242320 | BD Vacutainer® One Use Holder Becton, Dickinson and Company | JKA |
| Oct 31, 2024 | K240455 | BD Vacutainer® Citrate Blood Collection Tubes Becton, Dickinson and Company | GIM |
| Mar 15, 2024 | K233986 | BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL) Becton, Dickinson and Company | LON |
| Feb 2, 2024 | K231373 | BD Vacutainer® K2 EDTA Blood Collection Tubes Becton, Dickinson and Company | JKA |
| Jan 19, 2024 | K231237 | BD Vacutainer® Fluoride Blood Collection Tubes Becton, Dickinson and Company | JKA |
| Dec 20, 2023 | K230855 | BD Vacutainer® Serum Separator (SST) Blood Collection Tubes Becton, Dickinson and Company | JKA |
| Dec 1, 2023 | K230391 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube Becton, Dickinson and Company | JKA |
| Nov 27, 2023 | K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube Becton, Dickinson and Company | GIM |
| Aug 31, 2023 | K222563 | BD Kiestra IdentifA Becton, Dickinson and Company | QQV |
| Aug 25, 2023 | K213670 | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes Becton, Dickinson and Company | GIM |
| Jul 21, 2023 | K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe Becton, Dickinson and Company | NGT |
| Jul 17, 2023 | K213953 | BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes Becton, Dickinson and Company | JKA |
| Jun 7, 2023 | K230651 | BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) Becton, Dickinson and Company | JTN |
| Mar 24, 2023 | K222591 | BD BACTEC Plus Aerobic/F Culture Vials Becton, Dickinson and Company | MDB |
| Mar 24, 2023 | K222559 | BD BACTEC Myco/F Lytic Culture Vials Becton, Dickinson and Company | MDB |
| Mar 24, 2023 | K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holde Becton, Dickinson and Company | JKA |
| Mar 10, 2023 | K222478 | BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device Becton, Dickinson and Company | JKA |
| Mar 6, 2023 | K223653 | BD Vaginal Panel Becton, Dickinson and Company | PQA |
| Dec 28, 2022 | K223286 | BD AutoShield Duo Pen Needle Becton, Dickinson and Company | FMI |
| Dec 21, 2022 | K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) Becton, Dickinson and Company | JTN |
| Dec 16, 2022 | K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets Becton, Dickinson and Company | FMK |
| Sep 21, 2022 | K220607 | BD MAX Enteric Viral Panel Becton, Dickinson and Company | PCH |
| Aug 19, 2022 | K220193 | BD MAX Enteric Parasite Panel Becton, Dickinson and Company | PCH |
| Jul 28, 2022 | K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel Becton, Dickinson and Company | PCI |
| Jul 16, 2022 | K213955 | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub Becton, Dickinson and Company | QTI |
| Jul 1, 2022 | K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle Becton, Dickinson and Company | BSP |
| Jun 28, 2022 | K213478 | BD Pen Needle Becton, Dickinson and Company | FMI |
| May 19, 2022 | K210983 | BD Epilor Syringe Becton, Dickinson and Company | CAZ |
| May 10, 2022 | K210585 | BD CTGCTV2 Becton, Dickinson and Company | QEP |
| Mar 23, 2022 | K213616 | BD Surgiphor Antimicrobial Irrigation System Becton, Dickinson and Company | FQH |
| Mar 9, 2022 | K212499 | BD Insulin Syringe (0.3mL) Becton, Dickinson and Company | FMF |
| Feb 4, 2022 | K212724 | BD Vacutainer UltraTouch Push Button Blood Collection Set Becton, Dickinson and Company | JKA |
Newest 50 of 142.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2026 | Becton, Dickinson and Company ForeSight Elite Tissue Oximetry Cable REF HEMFSM10
UDI-DI code: 00690103210927
The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxyg Open, Classified |
MUD | K243781 |
| May 15, 2026 | Becton, Dickinson and Company Swan-Ganz Pacing Catheter, Models: D200F7; Open, Classified |
DYG | K233983 |
| May 15, 2026 | Becton, Dickinson and Company Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P Open, Classified |
DYG | K231248 |
| May 15, 2026 | Becton, Dickinson and Company Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8; Open, Classified |
DYB | K231248 K233824 |
| May 10, 2011 | Becton Dickinson and Company S5-7606 Silicone Oil injection Cannula 6mm Long - 20G
REF 585247
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and t Terminated |
HMX | None listed |
| May 10, 2011 | Becton Dickinson and Company S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G
REF 585246
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and t Terminated |
HMX | None listed |
| May 10, 2011 | Becton Dickinson and Company BD Visitec
High Viscosity Injector 6mm .90mm (20G) [Hammer]
Catalog Number: 585228
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed in Terminated |
HMX | None listed |
| May 10, 2011 | Becton Dickinson and Company BD Visitec
High Viscosity Injector 4mm [Hammer] .90 (20G)
Catalog Number: 585208
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into Terminated |
HMX | None listed |
| May 10, 2011 | Becton Dickinson and Company BD Visitec
High Viscosity Injector 6mm [Hammer] .90mm (20G)
Catalog Number: 585184
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed in Terminated |
HMX | None listed |
| May 10, 2011 | Becton Dickinson and Company BD Visitec
High Viscosity Injector 4mm .90 (20G) [Hammer]
REF 585173
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera an Terminated |
HMX | None listed |
| Dec 16, 2010 | Becton Dickinson and Company Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx
For Intraocular Use
REF 585304
Use as a surgical aid to protect corneal endothelium during cat Terminated |
LZP | None listed |
| May 21, 2010 | Becton Dickinson and Company BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454.
Intended for use in arthroscopic procedures. Terminated |
HTS | None listed |
| May 13, 2010 | Becton Dickinson and Company BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA.
Intended for use in cataract surgery to create self-sealing stab incisions through the cornea or sclera. Also used in retinal surge Terminated |
HNN | None listed |
| Oct 3, 2008 | Becton Dickinson and Company BD Visitec High Viscosity Injector, 4mm
Ref: 585173. The product is intended for Vitroretinal Surgery. Terminated |
HMX | None listed |
| Sep 19, 2008 | Becton Dickinson and Company BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile
Ref: 581440
Used during cataract and other ophthalmic surgery procedures to grasp lens capsule. Terminated |
HNR | None listed |
| Dec 11, 2007 | Becton Dickinson and Company BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #: 585793, Becton, Dickinson and Company, Waltham, MA 02452 Terminated |
HNM | None listed |
| Dec 11, 2007 | Becton Dickinson and Company BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF #: 585155, Becton, Dickinson and Company, Waltham, MA 02452 Terminated |
HNM | None listed |
| Oct 23, 2007 | Becton Dickinson and Company BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD) Terminated |
HMY | K023092 |
| Mar 29, 2007 | Becton Dickinson and Company BD Visitec Irrigating Cytosome, for use in cataract surgery.
Ref 581618 Terminated |
KYG | None listed |
| Feb 8, 2007 | Becton Dickinson and Company BD Beaver Mini-Blade, Mini/Bulk 69, Catalog Number: 374823 Terminated |
HNN | None listed |
| Feb 8, 2007 | Becton Dickinson and Company BD Beaver Mini-Blade, Mini/Bulk 67, Catalog Number: 374822 Terminated |
HNN | None listed |
| Feb 8, 2007 | Becton Dickinson and Company BD Beaver Mini-Blade, Mini/Bulk 64, Catalog Number: 374820 Terminated |
HNN | None listed |
| Feb 8, 2007 | Becton Dickinson and Company BD Beaver Mini-Blade, Blade Mini Sharp All Around S/SU, Catalog Number: 376900 Terminated |
HNN | None listed |
| Feb 8, 2007 | Becton Dickinson and Company BD Beaver Mini-Blade, Blade Mini Curved Sharp on One, Catalog Number: 376700 Terminated |
HNN | None listed |
| Feb 8, 2007 | Becton Dickinson and Company BD Beaver Mini-Blade, Blade Mini Pointed Tip S/SU, Catalog Number: 376500 Terminated |
HNN | None listed |
| Feb 8, 2007 | Becton Dickinson and Company BD Beaver Mini-Blade, Blade Mini RND Tip Sharp One Side, Catalog Number: 376400 Terminated |
HNN | None listed |
| Feb 8, 2007 | Becton Dickinson and Company BD Beaver Mini-Blade, Blade Sharp Two Sides Pointed, Catalog Number: 376300 Terminated |
HNN | None listed |
| Feb 8, 2007 | Becton Dickinson and Company BD Beaver Mini-Blade, Blade Mini Orthopedic 1.31 in, Catalog Number: 376100 Terminated |
HNN | None listed |
| Feb 8, 2007 | Becton Dickinson and Company BD Beaver Mini-Blade, Blade Mini Orthopedic 1.255 in, Catalog Number: 374562 Terminated |
HNN | None listed |