Data / Medical devices / Canada / Covalon Technologies Inc.

Covalon Technologies Inc.: FDA-registered device maker in MISSISSAUGA Ontario, Canada, 4 510(k) clearances

Name: Covalon Technologies Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Covalon Technologies Inc. is registered with the FDA (registration 3005004019) in MISSISSAUGA Ontario, Canada. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 9, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005004019
Address: 1660 Tech Avenue Unit 5, MISSISSAUGA Ontario, Canada, L4W 5S7
Owner or operator: COVALON TECHNOLOGIES, LTD. (9070081)
Roles: Complaint file establishment, Foreign private label distributor, Manufacturer, Specification developer
First device listed: February 4, 2005
Registered through: 2026
Brand names listed: ColActive Plus, ColActive Plus Ag, CovaClear IV, CovaView IV, CovaWound Alginate, CovaWound Foam;CovaWound Hydrocolloid;CovaWound Silicone;CovaWound Superabsorbent, IV Clear Antimicrobial Clear Silicone Adhesive Dressing With Chlorhexidine and Silver, SurgiClear Antimicrobial Clear Silicone Adhesive Dressing With Cholorhexidine and Silver

Devices it lists

Device	Product code	Class	Role	Source
Device, Intravascular Catheter Securement	KMK	1	Complaint file establishment, Foreign private label distributor, Specification developer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Complaint file establishment, Foreign private label distributor	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Complaint file establishment, Foreign private label distributor	accessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)	KGN	U	Complaint file establishment, 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
September 9, 2026	K260652	ColActive Plus	KGN	Substantially Equivalent	Covalon Technologies, Ltd.	accessdata.fda.gov
August 13, 2012	K121819	SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER	FRO	Substantially Equivalent	Covalontechnologies, Inc.	accessdata.fda.gov
May 4, 2012	K112549	IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER	FRO	Substantially Equivalent	Covalontechnologies, Inc.	accessdata.fda.gov
April 18, 2006	K060804	COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING	FRO	Substantially Equivalent	Covalon Technologies, Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 9, 2026. 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.