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Eusa Global LLC: FDA-registered device maker in Medley, FL, United States, 4 510(k) clearances

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

Eusa Global LLC is registered with the FDA (registration 3007532396) in Medley, FL, United States. It lists 20 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 26, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007532396
Address: 11801 NW 100th Rd Ste 17, Medley, FL, United States, 33178
Owner or operator: EUSA GLOBAL LLC (10034454)
Roles: Complaint file establishment, Contract manufacturer, Repackager or relabeler
First device listed: December 2, 2010
Registered through: 2026
Brand names listed: 2DHD Video Splitter, 3DHD Video Splitter, Colposcope C-200F, Colposcope C-200T, Colposcope C-200W, Colposcope C100, Colpsocope C-200A, EP and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Repackager or relabeler	accessdata.fda.gov
Camera, Television, Endoscopic, Without Audio	FWF	1	Contract manufacturer	accessdata.fda.gov
Camera, Television, Microsurgical, Without Audio	FWD	1	Contract manufacturer	accessdata.fda.gov
Colposcope (And Colpomicroscope)	HEX	2	Repackager or relabeler	accessdata.fda.gov
Flowmeter, Calibration, Gas	BXY	1	Repackager or relabeler	accessdata.fda.gov
Headlamp, Operating, Battery-Operated	HPP	1	Contract manufacturer	accessdata.fda.gov
Headlight, Fiberoptic Focusing	FCT	2	Contract manufacturer	accessdata.fda.gov
Laryngoscope, Nasopharyngoscope	EQN	2	Repackager or relabeler	accessdata.fda.gov
Laryngoscope, Non-Rigid	CAL	1	Repackager or relabeler	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Repackager or relabeler	accessdata.fda.gov
Laryngostroboscope	EQL	1	Contract manufacturer	accessdata.fda.gov
Led Light Source	NTN	2	Contract manufacturer	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Contract manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Repackager or relabeler	accessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	HRM	1	Contract manufacturer	accessdata.fda.gov
Microscope, Surgical	EPT	1	Contract manufacturer	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Nystagmograph	GWN	2	Repackager or relabeler	accessdata.fda.gov
Otoscope	ERA	1	Repackager or relabeler	accessdata.fda.gov
Source, Carrier, Fiberoptic Light	EQH	1	Contract 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
April 26, 2013	K130201	NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM	GWN	Substantially Equivalent	Ototronix, LLC	accessdata.fda.gov
July 9, 2010	K100595	ECLERIS MICROSTAR COLPOSCOPE	HEX	Substantially Equivalent	Ecleris USA	accessdata.fda.gov
April 1, 2003	K030572	HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE	EOB	Substantially Equivalent	Henke Sass Wolf of America, Inc.	accessdata.fda.gov
May 13, 1982	K821181	FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #	EQN	Substantially Equivalent	Machida America, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 26, 2013. 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.