Data / Medical devices / United States / Tricol Biomedical, INC.

Tricol Biomedical, INC.: FDA-registered device maker in Portland, OR, United States, 7 510(k) clearances

Name: Tricol Biomedical, INC. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tricol Biomedical, INC. is registered with the FDA (registration 3004050854) in Portland, OR, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 10, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004050854
Address: 720 SW Washington St Ste 200, Portland, OR, United States, 97205
Owner or operator: Tricol Biomedical, INC. (9053189)
Roles: Specification developer
First device listed: December 19, 2006
Registered through: 2026
Brand names listed: ChitoGauze XR PRO, ChitoGauze XR PRO (SafeGuard), ChitoGauze XR2 PRO, GuardaCare XR Surgical, HemCon Bandage PRO, HemCon ChitoDot, HemCon ChitoGauze (OTC), HemCon ChitoGauze PRO and more

Devices it lists

Device	Product code	Class	Role	Source
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Specification developer	accessdata.fda.gov
Oral Wound Dressing	OLR	U	Specification developer	accessdata.fda.gov
Splint, Intranasal Septal	LYA	1	Specification developer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Specification developer	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
November 10, 2015	K150916	HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO	QSY	Substantially Equivalent	Hem Con Medical Technologies, Inc.	accessdata.fda.gov
June 16, 2011	K103641	GUARDACARE	QSY	Substantially Equivalent	Hem Con Medical Technologies, Inc.	accessdata.fda.gov
November 17, 2010	K102546	CHITOGAUZE	QSY	Substantially Equivalent	Hem Con Medical Technologies, Inc.	accessdata.fda.gov
August 25, 2009	K092357	CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2	QSY	Substantially Equivalent	Hem Con Medical Technologies, Inc.	accessdata.fda.gov
May 15, 2008	K080818	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	QSY	Substantially Equivalent	Hem Con Medical Technologies, Inc.	accessdata.fda.gov
July 7, 2006	K060363	HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12	OLR	Substantially Equivalent	Hemcon, Inc.	accessdata.fda.gov
January 8, 2002	K010933	SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY	QSY	Substantially Equivalent	Alltracel Pharma , Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 10, 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.