Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002682307

FEI Number

3002682307

Entity Name

BECTON DICKINSON, S.A.

City/State/Country

FRAGA Huesca, ES

Establishment Address

CR MEQUINENZA, S/N, FRAGA Huesca 22520, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Becton Dickinson and Company (Owner Number: 9922032)

Owner / Operator Contact Address

One Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091377

PMA Number

N/A

All Registered Proprietary Names

BD PhaSeal Optima Closed System Drug Transfer Device BD Vacutainer® One Use Holder BD Plastipak BD Quincke Spinal Needle BD Spinal Introducer Needle BD Whitacre Spinal Needle BD Plastipak Syringe BD Hypodermic Syringe BD PosiFlush SP Syringe BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 Eclipse SmartSlip BD PosiFlush BD Flu+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2020-08-19
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-11-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-09-25
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2022-06-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-08-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-04
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2026-01-23
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2013-03-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-08-01
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2019-04-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-07-29

Official Correspondent

No official correspondent registered.

US Agent Details

John Roberts Email: john_w_roberts@bd.com Phone: (201) 8474760

Related Public Records

Same Entity

Becton Dickinson and Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680577	BECTON DICKINSON GMBH	HEIDELBERG Baden-Wurttemberg, DE
3003916417	BECTON DICKINSON IND. CIRURGICAS LTDA.	CURITIBA Parana, BR
3036495171	BD Biosciences San Diego	San Diego, CA, US
3015292643	BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES	San Diego, CA, US
3010141591	BD Kiestra B.V.	Drachten Fryslan, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002682307. Last updated year: 2026. Please use registration number 3002682307 when referencing this establishment in official correspondence.