Splint, Nasal (EPP): 20 FDA-registered makers in 8 countries

Name: FDA-registered makers of Splint, Nasal
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

20 establishments in 8 countries are registered with the FDA to make Splint, Nasal (product code EPP, Class 1, 21 CFR 874.5800). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on July 29, 1994, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: EPP
Device class: 1
Regulation: 874.5800
Medical specialty: Ear, Nose, Throat

Makers by country

Country	Makers
United States	7
Germany	4
India	2
Pakistan	2
China	2
Dominican Republic	1
Mexico	1
Belgium	1

Makers of Splint, Nasal

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	Recall events	Source
Bioseal	Placentia, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0	api.fda.gov
Covidien	- Santo Domingo, Dominican Republic	Contract manufacturer	0	api.fda.gov
E. Benson Hood Laboratories, Inc.	Pembroke, MA, United States	Manufacturer	0	api.fda.gov
Eon Meditech Pvt. Ltd.	Surat Gujarat, India	Contract manufacturer, Manufacturer	0	api.fda.gov
Fuhrmann GMBH	Much North Rhine-Westphalia, Germany	Contract manufacturer	0	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0	api.fda.gov
Guangdong Meicen Medical Equipment Co., Ltd.	foshan Guangdong, China	Manufacturer	0	api.fda.gov
Gesco Healthcare Private Limited	CHENNAI, Tamil Nadu, India	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Invotec International, Inc.	Jacksonville, FL, United States	Manufacturer	0	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	Contract manufacturer	0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Specification developer	0	api.fda.gov
Medtronic Xomed, Inc.	Jacksonville, FL, United States	Manufacturer	1	api.fda.gov
Nopa Instruments, Medizintechnik GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0	api.fda.gov
Orfit Industries NV	WIJNEGEM Antwerpen, Belgium	Manufacturer	0	api.fda.gov
Qibei Technology Co., Limited	KL Hong Kong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Spiggle & Theis Medizintechnik GMBH	OVERATH North Rhine-Westphalia, Germany	Manufacturer	0	api.fda.gov
Summit Medical LLC	Saint Paul, MN, United States	Contract manufacturer, Manufacturer, Manufacturer for export	0	api.fda.gov
Surgical Technology Laboratories Inc.	Lugoff, SC, United States	Manufacturer	0	api.fda.gov
Symmetry Surgical GmbH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0	api.fda.gov
Towne Brothers (pvt.), Ltd.	SIALKOT Punjab, Pakistan	Manufacturer	0	api.fda.gov

Updated July 29, 1994. 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.