Data / Medical devices / Philippines / Terumo (philippines) Corporation

Terumo (philippines) Corporation: FDA-registered device maker in BINAN Laguna, Philippines, 9 510(k) clearances

Name: Terumo (philippines) Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Terumo (philippines) Corporation is registered with the FDA (registration 3003902955) in BINAN Laguna, Philippines. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 16, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003902955
Address: No. 124 EAST MAIN AVE. LAGUNA TECHNOPARK, BINAN Laguna, Philippines, 4024
Owner or operator: Terumo (Philippines) Corporation (10033966)
Roles: Manufacturer
First device listed: October 22, 2010
Registered through: 2026
Brand names listed: McKesson Medi-Pak¿ Performance Needle, McKesson Prevent® HT Safety Hypodermic Needles, McKesson Prevent® HT Syringes with Safety Hypodermic Needles, SURFLO® I.V. Catheter, Terumo SurGuard3 Safety Hypodermic Needle, Terumo® Needle, Terumo® SurGuard® 2 Hypodermic Syringe with Safety Needle, Terumo® SurGuard® 2 Safety Hypodermic Needle and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	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
October 16, 2015	K152362	Terumo SurGuard 3 Safety Hypodermic Needle	FMI	Substantially Equivalent	Terumo (Philippines) Corporation	accessdata.fda.gov
June 12, 2014	K133280	TERUMO SURFLO I.V. CATHETER	FOZ	Substantially Equivalent	Terumo (Philippines) Corporation	accessdata.fda.gov
November 8, 2012	K121607	TERUMO(R) NEEDLE	FMI	Substantially Equivalent	Terumo (Philippines) Corporation	accessdata.fda.gov
August 28, 2012	K122249	TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE	FMI	Substantially Equivalent	Terumo (Philippines) Corporation	accessdata.fda.gov
March 5, 2012	K113422	TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE	FMI	Substantially Equivalent	Terumo (Philippines) Corporation	accessdata.fda.gov
December 26, 2006	K063613	MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE	FMF	Substantially Equivalent	Terumo Medical Corp.	accessdata.fda.gov
September 27, 2005	K051865	TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR	MEG	Substantially Equivalent	Terumo Medical Corp.	accessdata.fda.gov
August 16, 2005	K052034	TERUMO SYRINGE WITH/WITHOUT NEEDLE	FMF	Substantially Equivalent	Terumo Medical Corp.	accessdata.fda.gov
December 18, 2002	K023271	TERUMO SYRINGE WITH/WITHOUT NEEDLE	FMF	Substantially Equivalent	Terumo Medical Corp.	accessdata.fda.gov

Compare with other makers

Updated October 16, 2015. 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.