Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005548740

FEI Number

3005548740

Entity Name

WINFAME USA INC.

City/State/Country

Monrovia, CA, US

Establishment Address

710 S. Myrtle Ave, STE 189, Monrovia, CA 91016, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

WINFAME USA INC. (Owner Number: 9083124)

Owner / Operator Contact Address

5548 Welland Ave, Ste F, Temple City, CA 91780, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WF OPH CANNULA WF FORCEPTS Winfame Scleral Dejpressor double ends WFPST TRAYS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-03-19
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-03-19
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2023-01-18
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-03-19
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-03-19
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-03-19
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-03-19
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-03-19
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2008-03-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

WINFAME USA INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Similar Registrations

Registration Number	Establishment Name	Location
3034992373	PLU OPHTHALMIC Corp	Coral Gables, FL, US
3031572059	TissueGUARD	Dresden Saxony, DE
3008754084	Belle Healthcare Technology Co., Ltd.	Suzhou Jiangsu, CN
3008719017	SUMMIT MEDICAL LLC	Saint Paul, MN, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005548740. Last updated year: 2026. Please use registration number 3005548740 when referencing this establishment in official correspondence.