Data / Medical devices / System, Surgical, Computer Controlled Instrument / United States

FDA-registered makers of System, Surgical, Computer Controlled Instrument in the United States: 21 establishments

Name: FDA-registered makers of System, Surgical, Computer Controlled Instrument in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

21 establishments in the United States are registered with the FDA to make System, Surgical, Computer Controlled Instrument (product code NAY). 7 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device: System, Surgical, Computer Controlled Instrument
Product code: NAY
Country: United States

Makers of System, Surgical, Computer Controlled Instrument in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Class I	Source
Intuitive Surgical, Inc.	Sunnyvale, CA, United States	Manufacturer, Manufacturer for export, Specification developer	129	September 8, 2026	111	1	api.fda.gov
Intuitive Surgical, Inc.	Santa Clara, CA, United States	Complaint file establishment, Manufacturer for export	129	September 8, 2026	0	0	api.fda.gov
Intuitive Surgical, Inc.	Peachtree Corners, GA, United States	Manufacturer, Remanufacturer, Repackager or relabeler	44	January 16, 2026	0	0	api.fda.gov
Intuitive Surgical, Inc.	Sunnyvale, CA, United States	Manufacturer, Manufacturer for export	17	March 11, 2026	0	0	api.fda.gov
Intuitive Surgical, Inc.	Sunnyvale, CA, United States	Manufacturer	5	January 16, 2026	0	0	api.fda.gov
Intuitive Surgical, Inc.	Phoenix, AZ, United States	Manufacturer	2	March 14, 2024	0	0	api.fda.gov
Intuitive Surgical, Inc.	Sunnyvale, CA, United States	Manufacturer	1	March 16, 2023	0	0	api.fda.gov
Biomerics NLE	Monroe, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
Fabrinet West	Santa Clara, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Linemaster Switch Corp.	Woodstock, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
LISI MEDICAL REmmele	Big Lake, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
M&L Precision Machining Inc.	Morgan Hill, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Mass Precision, Inc.	Fremont, CA, United States	Contract manufacturer, Manufacturer for export	0		0	0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
ORIGAMI SURGICAL Inc.	Dover, MA, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
R.K. Manufacturing	Danbury, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
Restore Robotics Repairs LLC	Henderson, NV, United States	Remanufacturer	0		0	0	api.fda.gov
Samax Precision Inc.	Sunnyvale, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Supreme Screw Products	Plainview, NY, United States	Contract manufacturer	0		0	0	api.fda.gov
Tecan Cdmo Solutions MH, Corp.	Morgan Hill, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Veridiam, LLC	El Cajon, CA, 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.