Data / Medical devices / United States / Tecfen Medical

Tecfen Medical: FDA-registered device maker in Santa Barbara, CA, United States, 8 510(k) clearances

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

Tecfen Medical is registered with the FDA (registration 3010487482) in Santa Barbara, CA, United States. It lists 21 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 23, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010487482
Address: 6100 HOLLISTER AVENUE Building 3, Unit 3A/3B, Santa Barbara, CA, United States, 93117
Owner or operator: TECFEN MEDICAL (10047971)
Roles: Repackager or relabeler, Specification developer
First device listed: November 20, 2014
Registered through: 2026
Brand names listed: Eye Shield, Ophthalmic Patient Drape, Surgical Drape, Tecfen Iris Retractor, Tecfen Keratome Blade, Tecfen Laser Probes, Tecfen Medical Face Shield, Tecfen Medical Intranasal Septal Splint and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Repackager or relabeler	accessdata.fda.gov
Clip, Iris Retractor	HOC	1	Repackager or relabeler	accessdata.fda.gov
Drape, Patient, Ophthalmic	HMT	2	Repackager or relabeler	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Repackager or relabeler	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Repackager or relabeler	accessdata.fda.gov
Keratome, Ac-Powered	HNO	1	Repackager or relabeler	accessdata.fda.gov
Kit, Earmold, Impression	LDG	1	Repackager or relabeler	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Repackager or relabeler	accessdata.fda.gov
Laser, Ophthalmic	HQF	2	Repackager or relabeler	accessdata.fda.gov
Marker, Skin	FZZ	1	Repackager or relabeler	accessdata.fda.gov
Photocoagulator And Accessories	HQB	2	Repackager or relabeler	accessdata.fda.gov
Plug, Punctum	LZU	U	Repackager or relabeler	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Repackager or relabeler	accessdata.fda.gov
Splint, Intranasal Septal	LYA	1	Repackager or relabeler	accessdata.fda.gov
Sponge, Ophthalmic	HOZ	2	Repackager or relabeler	accessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)	HQY	1	Specification developer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Thermometer, Clinical Color Change	FQZ	1	Repackager or relabeler	accessdata.fda.gov
Trephine, Manual, Ophthalmic	HRH	1	Repackager or relabeler	accessdata.fda.gov
Tube, Tympanostomy	ETD	2	Repackager or relabeler	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 23, 2019	K191846	MAXReach Laser Probe	HQB	Substantially Equivalent	Vortex Surgical, Inc.	accessdata.fda.gov
June 25, 2015	K142830	Ophthalmed Bending Laser Probes	HQF	Substantially Equivalent	Ophthalmed, LLC	accessdata.fda.gov
October 29, 2013	K130117	NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS	HOZ	Substantially Equivalent	Network Medical Products, Ltd.	accessdata.fda.gov
October 4, 2010	K101598	EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)	KKX	Substantially Equivalent	Exact Medical Manufacturing, Inc.	accessdata.fda.gov
August 19, 2005	K050851	DELTA PUNCTUM PLUG	LZU	Substantially Equivalent	Delta Life Science, Inc.	accessdata.fda.gov
May 25, 2004	K033457	M2 COMPATIBLE MICROKERATOME BLADE	HNO	Substantially Equivalent	Micro Specialties, Inc.	accessdata.fda.gov
May 23, 1986	K861531	DISPOSABLE SURGICAL DRAPES AND ACCESSORIES	KKX	Substantially Equivalent	Medical Concepts Development, Inc.	accessdata.fda.gov
March 7, 1983	K830228	OTOLOGICAL VENTILATION TUBES-VARIOUS	ETD	Substantially Equivalent	Micromedics, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 25, 2025	96872	Class II	Ongoing	Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation)	Sterility assurance for Ophthalmic knives.	accessdata.fda.gov

Compare with other makers

Updated June 11, 2025. 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.