Data / Medical devices / Applier, Staple, Surgical,

Applier, Staple, Surgical, (GEF): 20 FDA-registered makers in 7 countries

Name: FDA-registered makers of Applier, Staple, Surgical,
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

20 establishments in 7 countries are registered with the FDA to make Applier, Staple, Surgical, (product code GEF, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on November 23, 1993, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: GEF
Device class: 1
Regulation: 878.4800
Medical specialty: General, Plastic Surgery

Makers by country

Country	Makers
United States	7
Pakistan	4
Germany	3
China	3
Malaysia	1
Mexico	1
Switzerland	1

Makers of Applier, Staple, Surgical,

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	Source
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
B. Ali Impex	SIALKOT, Punjab, Pakistan	Manufacturer	api.fda.gov
B. Braun Medical Industries Sdn. Bhd.	PENANG Pulau Pinang, Malaysia	Contract manufacturer	api.fda.gov
Changzhou 3R Medical Device Technology Co., Ltd.	Changzhou Jiangsu, China	Manufacturer	api.fda.gov
Conmed Corporation	Utica, NY, United States	Manufacturer	api.fda.gov
Covidien	North Haven, CT, United States	Manufacturer, Specification developer	api.fda.gov
Covidien	Ponce, PR, United States	Manufacturer	api.fda.gov
Dimeda Instrumente GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	api.fda.gov
Ethicon, Inc.	CIUDAD JUAREZ Chihuahua, Mexico	Contract manufacturer	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	api.fda.gov
Hive International Pvt Ltd.	Sialkot Punjab, Pakistan	Manufacturer	api.fda.gov
Med2b Ltd.	Kitzingen Bavaria, Germany	Manufacturer	api.fda.gov
Medos International Sarl	Le Locle Neuchatel, Switzerland	Specification developer	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	api.fda.gov
Surgicon Pvt Ltd	Sialkot Punjab, Pakistan	Manufacturer	api.fda.gov
Svenson Network Holdings Limited	HK Hong Kong, China	Manufacturer	api.fda.gov
Xinhua Surgical Instrument Co. Ltd.	ZIBO Shandong, China	Manufacturer	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	api.fda.gov

Updated November 23, 1993. 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.