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Becton Dickinson Medical (singapore): FDA-registered device maker in SINGAPORE North West, Singapore, 10 510(k) clearances

Name: Becton Dickinson Medical (singapore) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Becton Dickinson Medical (singapore) is registered with the FDA (registration 8041187) in SINGAPORE North West, Singapore. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 19, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8041187
FEI number: 1000174591
Address: 30 Tuas Avenue 2, SINGAPORE North West, Singapore, 639461
Owner or operator: Becton Dickinson and Company (9922032)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: December 4, 2007
Registered through: 2026
Brand names listed: BD 1mL Luer-Lok Hypodermic Syringe, BD 1mL Luer-Lok Hypodermic Syringe with BD Eclipse Hypodermic Needle, BD 1mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle, BD 1mL Luer-Lok Insulin Syringe, BD 1ml Insulin Syringe U-100 Luer-Lok Tip, BD 1ml Syringe Luer-Lok Tip, BD 1ml Syringe Luer-Lok Tip with BD PrecisionGlide Needle, BD Angiocath IV Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Syringe, Piston	FMF	2	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 19, 2016	K162081	BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
December 9, 2016	K162516	BD Pen Needle	FMI	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
May 27, 2016	K161170	BD Eclipse Hypodermic Needle	FMI	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 27, 2015	K151698	BD Angiocath IV Catheter, BD Insyte IV Catheter	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
May 13, 2011	K110771	BD SINGLE USE, HYPODERMIC SYRINGE	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
March 16, 2007	K070440	BD HYPOINT NEEDLE	FMI	Substantially Equivalent	Becton, Dickinson & CO	accessdata.fda.gov
July 19, 2002	K021475	BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET	FMI	Substantially Equivalent	Bd	accessdata.fda.gov
March 1, 2001	K010188	BD ECLIPSE HYPODERMIC NEEDLE	FMI	Substantially Equivalent	Bd Medical Systems	accessdata.fda.gov
June 11, 1998	K980987	BECTON DICKINSON SYRINGE	FMF	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov
May 26, 1994	K941562	1ML LUER-LOK SYRINGE	FMF	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov

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Updated December 19, 2016. 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.