Data / Medical devices / Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece / United States

FDA-registered makers of Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece in the United States: 38 establishments

Name: FDA-registered makers of Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

38 establishments in the United States are registered with the FDA to make Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (product code ERL). 11 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Product code: ERL
Country: United States

Makers of Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Medtronic Xomed, Inc.	Jacksonville, FL, United States	Complaint file establishment, Manufacturer	10	August 14, 2015	3	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	9	June 9, 2021	0	api.fda.gov
Gyrus ACMI, Inc.	Brooklyn Park, MN, United States	Complaint file establishment, Manufacturer, Specification developer	6	January 19, 2022	0	api.fda.gov
Stryker Puerto Rico, LLC.	Arroyo, PR, United States	Contract manufacturer, Manufacturer	3	May 1, 2012	0	api.fda.gov
The Anspach Effort, Inc.	Palm Bch Gdns, FL, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	3	March 27, 2018	6	api.fda.gov
Gyrus Acmi, Inc.	Bartlett, TN, United States	Manufacturer	2	June 10, 2016	0	api.fda.gov
Grace Medical, Inc.	Memphis, TN, United States	Manufacturer	1	August 25, 2016	0	api.fda.gov
Gyrus Acmi, Inc.	Westborough, MA, United States	Specification developer	1	January 19, 2022	0	api.fda.gov
Interscope, Inc.	Northbridge, MA, United States	Manufacturer	1	December 13, 2019	0	api.fda.gov
Medtronic Powered Surgical Solutions	Fort Worth, TX, United States	Manufacturer, Specification developer	1	September 5, 2008	0	api.fda.gov
Stryker Endoscopy	San Jose, CA, United States	Manufacturer	1	July 20, 1995	0	api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)	Riviera Beach, FL, United States	Contract manufacturer	0		0	api.fda.gov
Acclarent, Inc.	Irvine, CA, United States	Specification developer	0		0	api.fda.gov
Benchmark Electronics, Inc.	Winona, MN, United States	Contract manufacturer	0		0	api.fda.gov
Benchmark Electronics, Inc.	Rochester, MN, United States	Contract manufacturer	0		0	api.fda.gov
Cadence Device, Inc.	Cranberry Township, PA, United States	Contract manufacturer	0		0	api.fda.gov
Command Medical Products, LLC.	Ormond Beach, FL, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, 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
K2M, Inc.	Leesburg, VA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Kimball Solutions - Indianapolis	Indianapolis, IN, United States	Contract manufacturer	0		0	api.fda.gov
Kimball Solutions Jasper, Inc.	Jasper, IN, United States	Contract manufacturer	0		0	api.fda.gov
Linemaster Switch Corp.	Woodstock, CT, United States	Contract manufacturer	0		0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Specification developer	0		0	api.fda.gov
Medtronic Puerto Rico Operations Co., Humacao	Humacao, PR, United States	Manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
Nico Corporation	Indianapolis, IN, United States	Specification developer	0		0	api.fda.gov
Nypro Inc (Maple Grove)	Maple Grove, MN, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, 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
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0		0	api.fda.gov
Primo Medical Group, Inc	W Bridgewater, MA, United States	Contract manufacturer	0		0	api.fda.gov
R.H. Cross Enterprises, Inc.	Portage, MI, United States	Contract manufacturer	0		0	api.fda.gov
Stryker Manufacturing Kalamazoo	Portage, MI, United States	Contract manufacturer	0		0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Specification developer	0		0	api.fda.gov
Vaupell Midwest Molding and Tooling	Constantine, MI, United States	Contract 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.