Data / Medical devices / Bur, Surgical, General & Plastic Surgery / United States

FDA-registered makers of Bur, Surgical, General & Plastic Surgery in the United States: 52 establishments

Name: FDA-registered makers of Bur, Surgical, General & Plastic Surgery in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

52 establishments in the United States are registered with the FDA to make Bur, Surgical, General & Plastic Surgery (product code GFF). 1 has a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in the United States Watch these makers

Device: Bur, Surgical, General & Plastic Surgery
Product code: GFF
Country: United States

Makers of Bur, Surgical, General & Plastic Surgery in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Brasseler U.S.A. Medical, LLC	Savannah, GA, United States	Manufacturer, Repackager or relabeler, Specification developer	3	August 22, 1994	1	api.fda.gov
Abrasive Technology, LLC	Lewis Center, OH, United States	Manufacturer	0		0	api.fda.gov
American Medicals	Jacksonville, FL, United States	Specification developer	0		0	api.fda.gov
Armm, Inc.	Huntington Beach, CA, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0		1	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Aurora Surgical, LLC	St Petersburg, FL, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Arthrex Logistic Center	Fort Myers, FL, United States	Manufacturer	0		0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Manufacturer	0		0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
B & M Precision, Inc.	Ruskin, FL, United States	Contract manufacturer	0		0	api.fda.gov
Bioaccess, Inc.	Baltimore, MD, United States	Specification developer	0		0	api.fda.gov
Bausch & Lomb Incorporated	Manchester, MO, United States	Manufacturer	0		0	api.fda.gov
Fetzer Surgical, LLC	Scottsdale, AZ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
HPC Medx	Hanover, PA, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Elmira)	Horseheads, NY, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	api.fda.gov
Lasco Diamond Products, Inc.	Chatsworth, CA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer	0		1	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Manufacturing Technology And Services, LLC	Oxford, AL, United States	Contract manufacturer	0		0	api.fda.gov
Mclean Medical & Scientific	Saint Paul, MN, United States	Contract manufacturer	0		0	api.fda.gov
Medtronic Xomed, Inc.	Jacksonville, FL, United States	Manufacturer	0		1	api.fda.gov
Microaire Surgical Instruments LLC	Charlottesville, VA, United States	Manufacturer	0		0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Reprocessor	0		1	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Nuell, Inc.	Leesburg, IN, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Nypro Inc (Maple Grove)	Maple Grove, MN, United States	Contract manufacturer	0		0	api.fda.gov
Omega Surgical Instruments, Inc.	Flint, MI, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Orthopedic Sciences, Inc	Overland Park, KS, United States	Specification developer	0		0	api.fda.gov
Osteomed	Addison, TX, United States	Manufacturer	0		0	api.fda.gov
Phoenix Instruments, Inc.	Lisle, IL, United States	Contract manufacturer	0		0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	api.fda.gov
Renovo, Inc.	Bend, OR, United States	Reprocessor	0		0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	Specification developer	0		0	api.fda.gov
Stryker Endoscopy	San Jose, CA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Stryker Manufacturing Kalamazoo	Portage, MI, United States	Contract manufacturer	0		0	api.fda.gov
Stryker Puerto Rico, LLC.	Arroyo, PR, United States	Manufacturer	0		0	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Tritex Medical Manufacturing LLC	Mount Morris, MI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Velocity Orthopedics, Inc.	Rancho Cucamonga, CA, United States	Manufacturer	0		0	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	Manufacturer	0		0	api.fda.gov

Updated November 2, 2026. 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.