Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8041187

FEI Number

1000174591

Entity Name

BECTON DICKINSON MEDICAL (SINGAPORE)

City/State/Country

SINGAPORE North West, SG

Establishment Address

30 TUAS AVENUE 2, SINGAPORE North West 639461, SG

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

K162081

PMA Number

N/A

All Registered Proprietary Names

BD Nexiva Closed IV Catheter System BD Insyte IV Catheter BD Angiocath IV Catheter BD Insyte IV Catheter Eclipse BD Hypodermic Syringe BD Hypodermic Syringe BD Pen Needle BD Cathena Safety IV Catheter BD Neoflon Pro Safety IV Catheter BD Hypoint BD Syringe BD Insyte IV Catheter BD Angiocath IV Catheter BD 1ml Insulin Syringe U-100 Luer-Lok Tip BD 1mL Luer-Lok Insulin Syringe BD 1mL Luer-Lok Hypodermic Syringe with BD Eclipse Hypodermic Needle BD Eclipse Injection Needle with BD Luer-Lok Syringe BD 1mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle BD 1ml Syringe Luer-Lok Tip BD 1mL Luer-Lok Hypodermic Syringe BD 1ml Syringe Luer-Lok Tip with BD PrecisionGlide Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2019-03-29
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-04-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-05-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-08-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-02-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-08-01
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-08-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-03-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-06-03
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-04-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-01-05

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
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
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

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-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8041187. Last updated year: 2026. Please use registration number 8041187 when referencing this establishment in official correspondence.