Data / Medical devices / Neurological Stereotaxic Instrument / United States

FDA-registered makers of Neurological Stereotaxic Instrument in the United States: 110 establishments

Name: FDA-registered makers of Neurological Stereotaxic Instrument in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

110 establishments in the United States are registered with the FDA to make Neurological Stereotaxic Instrument (product code HAW). 34 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device: Neurological Stereotaxic Instrument
Product code: HAW
Country: United States

Makers of Neurological Stereotaxic Instrument in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Class I	Source
Medtronic Navigation, Inc.	Lafayette, CO, United States	Manufacturer, Repackager or relabeler, Specification developer	41	March 26, 2026	35	7	api.fda.gov
FHC, Inc.	Bowdoin, ME, United States	Complaint file establishment, Manufacturer	9	July 26, 2012	6	1	api.fda.gov
ClearPoint Neuro Inc.	Carlsbad, CA, United States	Manufacturer	7	January 24, 2025	0	0	api.fda.gov
Integra Lifesciences Corporation	Cincinnati, OH, United States	Manufacturer	5	December 6, 2016	0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	5	January 14, 2005	0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	5	January 14, 2005	0	0	api.fda.gov
Izi Medical Products LLC	Owings Mills, MD, United States	Manufacturer, Repackager or relabeler	4	April 13, 2015	0	0	api.fda.gov
COMPASS International Innovations, Inc.	Rochester, MN, United States	Manufacturer, Specification developer	3	August 19, 1997	0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler, Specification developer	3	May 23, 2007	0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer, Specification developer	3	May 23, 2007	0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	3	January 14, 2005	0	0	api.fda.gov
Ad-Tech Medical Instrument Corp.	Oak Creek, WI, United States	Manufacturer	2	April 24, 2012	0	0	api.fda.gov
Integra Pain Management	West Valley City, UT, United States	Manufacturer, Repackager or relabeler	2	December 6, 2016	0	0	api.fda.gov
Medtronic Xomed, Inc.	Jacksonville, FL, United States	Manufacturer	2	August 7, 2013	1	0	api.fda.gov
Navinetics Inc.	Rochester, MN, United States	Specification developer	2	July 14, 2023	1	0	api.fda.gov
Stryker Spine	Allendale, NJ, United States	Complaint file establishment, Manufacturer, Specification developer	2	June 5, 2014	0	0	api.fda.gov
Zeta Surgical Inc.	Boston, MA, United States	Manufacturer	2	May 1, 2026	0	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	1	March 21, 2006	1	0	api.fda.gov
FHC, Inc	Greenville, PA, United States	Manufacturer	1	February 12, 2010	0	0	api.fda.gov
GSB LLC	Nashville, TN, United States	Complaint file establishment, Manufacturer	1	March 6, 2014	0	0	api.fda.gov
Hill-Rom, Inc.	Batesville, IN, United States	Manufacturer	1	June 12, 2000	0	0	api.fda.gov
Intravent Medical Partners LP	Blue Bell, PA, United States	Specification developer	1	September 5, 2025	0	0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer	1	March 17, 1983	0	0	api.fda.gov
Medivis, Inc.	New York, NY, United States	Manufacturer	1	October 21, 2025	0	0	api.fda.gov
Medtronic Powered Surgical Solutions	Fort Worth, TX, United States	Manufacturer	1	November 1, 2019	0	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer	1	June 12, 2000	0	0	api.fda.gov
Materialise USA, LLC.	Plymouth, MI, United States	Manufacturer	1	March 27, 2012	0	0	api.fda.gov
Med-Surgical Services	Tucson, AZ, United States	Manufacturer	1	March 13, 2000	0	0	api.fda.gov
Medtronic Grand Rapids	Grand Rapids, MI, United States	Manufacturer	1	May 3, 2000	0	0	api.fda.gov
Neurodynamics, Inc.	Manhattan, NY, United States	Specification developer	1	February 20, 1986	0	0	api.fda.gov
Phasor Health, LLC	Houston, TX, United States	Complaint file establishment, Manufacturer	1	July 9, 2025	0	0	api.fda.gov
PMT Corp.	Chanhassen, MN, United States	Manufacturer	1	June 15, 1983	0	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	1	June 22, 2004	0	0	api.fda.gov
Spinal Elements, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	1	April 7, 2005	0	0	api.fda.gov
Alden Tool Company, Inc.	Berlin, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
American Industrial Plastics, LLC	Daytona Beach, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
American Manufacturing And Engineering	Montgomeryville, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Olive Branch	Olive Branch, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH-MedTorque	Kenosha, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Axial Medical	Ivyland, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
B & G MFG. Co.	Hatfield, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Branch Medical Group	Eagleville, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Branch Medical Group	Limerick, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
CEA Medical Manufacturing, Inc.	Colorado Springs, CO, United States	Contract manufacturer	0		0	0	api.fda.gov
Classic Wire Cut Company, Inc.	Valencia, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	0		0	0	api.fda.gov
Elite Medical, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Elite Medical, LLC	Florence, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Ferry Machine Corporation	Oakland, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
First Article Inc	Souderton, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Flex-Cell Precision, Inc.	Lancaster, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Flexbar Machine Corp.	Islandia, NY, United States	Contract manufacturer	0		0	0	api.fda.gov
Ferry Machine Corporation	Little Ferry, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0		1	0	api.fda.gov
Globus Medical, Inc.	Methuen, MA, United States	Manufacturer	0		0	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Harwood Design, Inc.	Bristol, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0		0	0	api.fda.gov
I-Tek Medical, Inc.	White Bear Lake, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Insert Molding Solutions, Inc.	Cumming, GA, United States	Contract manufacturer	0		0	0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
J & J Precision Technologies, LLC	Lititz, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
J&B Precision, Inc.	Cordova, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Jatex, Inc.	Nappanee, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	0	api.fda.gov
Life Science Outsourcing, Inc.	Brea, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Lowell,inc.	Brooklyn Park, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Mackay Manufacturing, Inc.	Spokane Valley, WA, United States	Contract manufacturer	0		0	0	api.fda.gov
Magnus Medical Inc.	Burlingame, CA, United States	Manufacturer	0		0	0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Matrix Machining Technologies, Inc.	Memphis, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Mclean Medical & Scientific	Saint Paul, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Monteris Medical Corp	Minnetonka, MN, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
MSK Precision Products, Inc.	Tamarac, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Multisource Manufacturing LLC	Longmont, CO, United States	Contract manufacturer	0		0	0	api.fda.gov
Nuvasive, Inc.	Guaynabo, PR, United States	Manufacturer	0		0	0	api.fda.gov
Nuvasive, Inc.	San Diego, CA, United States	Manufacturer	0		0	0	api.fda.gov
NextPhase Medical Devices LLC	Rochester, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Onyx Healthcare Usa, Inc.	Orange, CA, United States	Manufacturer	0		0	0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Packaging Compliance Medical, LLC	Kentwood, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Plexus Corp.	Buffalo Grove, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Quality Tech Services, LLC	Shakopee, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Remington Medical, Inc.	Alpharetta, GA, United States	Contract manufacturer	0		0	0	api.fda.gov
Remington Medical, Inc.	Alpharetta, GA, United States	Contract manufacturer	0		0	0	api.fda.gov
Structure Medical, LLC.	Naples, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Surgical Technologies, Inc.	St. Paul, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Spartronics Watertown LLC	Watertown, SD, United States	Contract manufacturer	0		0	0	api.fda.gov
Turner Medical Inc.	Athens, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Victoria Precision Inc.	Trevose, PA, United States	Contract manufacturer	0		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.