Data / Medical devices / Spain / Becton Dickinson, S.A.

Becton Dickinson, S.A.: FDA-registered device maker in FRAGA Huesca, Spain, 6 510(k) clearances

Name: Becton Dickinson, S.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Becton Dickinson, S.A. is registered with the FDA (registration 3002682307) in FRAGA Huesca, Spain. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 2, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002682307
Address: CR Mequinenza, S/N, FRAGA Huesca, Spain, 22520
Owner or operator: Becton Dickinson and Company (9922032)
Roles: Contract sterilizer, Manufacturer
First device listed: December 4, 2007
Registered through: 2026
Brand names listed: BD Flu+, BD Hypodermic Syringe, BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE, BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55, BD PhaSeal Optima Closed System Drug Transfer Device, BD PhaSeal Optima Closed System Transfer Device, BD PhaSeal Optima Connecting Set (C83-O), BD PhaSeal Optima Spike Set (C180-O) and more

Devices it lists

Device	Product code	Class	Role	Source
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	ONB	2	Contract sterilizer	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Contract sterilizer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
Saline, Vascular Access Flush	NGT	2	Manufacturer	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Contract sterilizer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract sterilizer, Manufacturer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 2, 2025	K250884	0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe	NGT	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
November 1, 2024	K242320	BD Vacutainer® One Use Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
February 2, 2017	K161552	0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe	NGT	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 25, 2014	K141311	0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE	NGT	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
February 19, 2010	K100209	BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY	FMI	Substantially Equivalent	Becton, Dickinson & CO	accessdata.fda.gov
July 2, 2009	K091377	BD FLU+ SYRINGE	FMF	Substantially Equivalent	Becton, Dickinson & CO	accessdata.fda.gov

Compare with other makers

Updated December 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.