Data / Medical devices / Medical Device Data System / United States

FDA-registered makers of Medical Device Data System in the United States: 145 establishments

Name: FDA-registered makers of Medical Device Data System in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

145 establishments in the United States are registered with the FDA to make Medical Device Data System (product code OUG). 0 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device: Medical Device Data System
Product code: OUG
Country: United States

Makers of Medical Device Data System in the United States

Maker	Location	Role	Recall events	Source
Abbott Diabetes Care Inc.	Alameda, CA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Abbott Medical	Sylmar, CA, United States	Manufacturer	0	api.fda.gov
Abiomed, Inc.	Danvers, MA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Active Protective Technologies, Inc.	Conshohocken, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
Actuvi	Dallas, TX, United States	Manufacturer	0	api.fda.gov
Advanced Sterilization Products	Irvine, CA, United States	Specification developer	0	api.fda.gov
Aiq Solutions	Madison, WI, United States	Manufacturer	0	api.fda.gov
American Portwell Technology, Inc.	Fremont, CA, United States	Manufacturer	0	api.fda.gov
Apneicare, LLC	Columbus, OH, United States	Manufacturer, Specification developer	0	api.fda.gov
Aqp One, Inc.	Garden Grove, CA, United States	Manufacturer	0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0	api.fda.gov
Ascend Cardiovascular LLC	Springfield, IL, United States	Manufacturer	0	api.fda.gov
Aventusoft	Boca Raton, FL, United States	Manufacturer	0	api.fda.gov
Avive Solutions Inc	Brisbane, CA, United States	Manufacturer	0	api.fda.gov
ActiGraph L.L.C.	Pensacola, FL, United States	Manufacturer, Repackager or relabeler, Specification developer	0	api.fda.gov
AliveCor	Mountain View, CA, United States	Manufacturer	0	api.fda.gov
Arthrex California Technology, Incorporated	Santa Barbara, CA, United States	Contract manufacturer	0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0	api.fda.gov
Avnet, Inc. (Avnet Logistics)	Chandler, AZ, United States	Contract manufacturer	0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Becton, Dickinson And Company	Irvine, CA, United States	Specification developer	0	api.fda.gov
Behavidence, Inc.	New York, NY, United States	Specification developer	0	api.fda.gov
Benchmark Electronics, Inc.	Winona, MN, United States	Contract manufacturer	0	api.fda.gov
Biobrdige Global	San Antonio, TX, United States	Manufacturer	0	api.fda.gov
Boston Brace International, Incorporated	Stoughton, MA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Bayer Medical Care Inc.	Indianola, PA, United States	Specification developer	0	api.fda.gov
Bayer Medical Care Inc.	Pittsburgh, PA, United States	Manufacturer	0	api.fda.gov
Beacon Biosignals - Cleveland Site	Cleveland, OH, United States	Specification developer	0	api.fda.gov
Beckman Coulter, Inc.	West Sacramento, CA, United States	Manufacturer	0	api.fda.gov
Bongiovi Medical and Health Technologies, LLC	Port Saint Lucie, FL, United States	Manufacturer	0	api.fda.gov
Boston Scientific Corporation	Saint Paul, MN, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Canary Medical Usa LLC	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Care Everywhere LLC	Natick, MA, United States	Manufacturer	0	api.fda.gov
Caregility Corporation	Wall Township, NJ, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Ceiba Healthcare Technologies LLC	New York, NY, United States	Manufacturer	0	api.fda.gov
Cloudphysician.ai	Wilmington, DE, United States	Manufacturer	0	api.fda.gov
Computer MD	Fort Lauderdale, FL, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
CapsoVision, Inc.	Saratoga, CA, United States	Manufacturer	0	api.fda.gov
Circadia Health, Inc.	El Segundo, CA, United States	Specification developer	0	api.fda.gov
Collaborative Care Diagnostics LLC dba BioMedix	Eagan, MN, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Covidien	Lafayette, CO, United States	Manufacturer, Specification developer	0	api.fda.gov
Element Science, Inc.	Redwood City, CA, United States	Manufacturer	0	api.fda.gov
Enlitenai Inc	Tracy, CA, United States	Manufacturer	0	api.fda.gov
Equitar Technologies, Inc.	La Jolla, CA, United States	Manufacturer	0	api.fda.gov
Etiometry Inc.	Dedham, MA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Eyeque Corporation	Newark, CA, United States	Manufacturer, Specification developer	0	api.fda.gov
Fenwal, Inc.	Lake Zurich, IL, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Foreseeson Custom Displays, Inc.	Anaheim, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
Gome Optical Lens Company Limited	Yonkers, NY, United States	Manufacturer	0	api.fda.gov
Gabriel International Inc.	Honolulu, HI, United States	Manufacturer	0	api.fda.gov
GlobalMed Holdings, LLC	Scottsdale, AZ, United States	Manufacturer	0	api.fda.gov
Glooko Inc	Palo Alto, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Haemonetics Corporation	Boston, MA, United States	Manufacturer	0	api.fda.gov
Healtharc LLC	Hackensack, NJ, United States	Manufacturer	0	api.fda.gov
Healthcare-Id, Inc.	Buffalo Grove, IL, United States	Manufacturer	0	api.fda.gov
Hill-Rom, Inc.	Raleigh, NC, United States	Manufacturer	0	api.fda.gov
Horiba Instruments Incorporated	Irvine, CA, United States	Manufacturer	1	api.fda.gov
Henry Schein One, LLC	Ames, IA, United States	Manufacturer	0	api.fda.gov
Hologic, Inc.	Marlborough, MA, United States	Manufacturer	0	api.fda.gov
HyperMed Technologies Corp.	Grand Forks, ND, United States	Manufacturer, Specification developer	0	api.fda.gov
Icu Medical, Inc.	Lake Forest, IL, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Infinium Medical, Inc.	Largo, FL, United States	Manufacturer	0	api.fda.gov
Innovision Medical Technologies, LLC	Baltimore, MD, United States	Specification developer	0	api.fda.gov
Instrumentation Laboratory Co.	Bedford, MA, United States	Manufacturer	0	api.fda.gov
Imalogix LLC	Bryn Mawr, PA, United States	Manufacturer	0	api.fda.gov
Jam-Labs Corp	Fremont, CA, United States	Specification developer	0	api.fda.gov
JWP Manufacturing	Santa Clara, CA, United States	Manufacturer	0	api.fda.gov
KESTRA Medical Technologies, Inc.	Kirkland, WA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Kimball Solutions Jasper, Inc.	Jasper, IN, United States	Contract manufacturer	0	api.fda.gov
Laborie Medical Technologies Corp.	Portsmouth, NH, United States	Manufacturer	0	api.fda.gov
Laitek Inc.	Loveland, CO, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
LifeBot Inc	Chicago, IL, United States	Manufacturer	0	api.fda.gov
Masimo Corporation	Irvine, CA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Matrix Biologics Inc.	Scottsdale, AZ, United States	Specification developer	0	api.fda.gov
Medical Digital Developers LLC	New Rochelle, NY, United States	Manufacturer	0	api.fda.gov
Medtronic Minimed	Northridge, CA, United States	Complaint file establishment, Manufacturer	1	api.fda.gov
Medtronic Neuromodulation	Minneapolis, MN, United States	Manufacturer	0	api.fda.gov
Medtronic, Inc.	Mounds View, MN, United States	Manufacturer, Specification developer	0	api.fda.gov
Microhealth Inc.	Cambridge, MA, United States	Manufacturer	0	api.fda.gov
Midmark Corporation	Versailles, OH, United States	Manufacturer	0	api.fda.gov
Mim Software Inc.	Cleveland, OH, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Mobilehelp LLC	Philadelphia, PA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Monitair, LLC	Miami, FL, United States	Manufacturer	0	api.fda.gov
Monitored Therapeutics, Inc.	Dublin, OH, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Medical Informatics Corp.	Houston, TX, United States	Manufacturer	0	api.fda.gov
Medtronic, Inc.	Tempe, AZ, United States	Manufacturer	0	api.fda.gov
Mirac, LLC	Lynchburg, OH, United States	Contract manufacturer	0	api.fda.gov
Motive Health, Inc.	Tempe, AZ, United States	Manufacturer, Specification developer	0	api.fda.gov
Murata Vios, Inc.	Woodbury, MN, United States	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	0	api.fda.gov
Neximatic Inc	North Waltham, MA, United States	Manufacturer	0	api.fda.gov
Nonin Medical, Inc.	Plymouth, MN, United States	Manufacturer	0	api.fda.gov
Novarad Corp.	Provo, UT, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Ordinatrum Health	Tustin, CA, United States	Manufacturer	0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	0	api.fda.gov
Orthogrid Systems, Inc	Midvale, UT, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
PAINKARE SOLUTIONS inc.	Peachtree City, GA, United States	Manufacturer	0	api.fda.gov
Peerbridge Health, Inc.	Franklin, TN, United States	Manufacturer	0	api.fda.gov
Phantom Laboratory	Greenwich, NY, United States	Manufacturer	0	api.fda.gov
Potrero Medical, Inc.	Hayward, CA, United States	Manufacturer	0	api.fda.gov
Prolaio Inc.	Chicago, IL, United States	Manufacturer	0	api.fda.gov
Prosomnus Sleep Technologies	Pleasanton, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Pfizer Inc	Parsippany, NJ, United States	Manufacturer for export	0	api.fda.gov
Philips North America LLC	Cambridge, MA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Philips North America LLC	Andover, MA, United States	Specification developer	2	api.fda.gov
Philips North America LLC	Murrysville, PA, United States	Contract manufacturer	0	api.fda.gov
Philips North America LLC	Export, PA, United States	Contract manufacturer	0	api.fda.gov
Polymer Technology Systems	Whitestown, IN, United States	Manufacturer	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0	api.fda.gov
Radformation, Inc.	New York, NY, United States	Manufacturer	0	api.fda.gov
Rauland-Borg Corporation	Mount Prospect, IL, United States	Manufacturer	0	api.fda.gov
Respironics Inc.	Murrysville, PA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Respironics, Inc.	New Kensington, PA, United States	Manufacturer	0	api.fda.gov
RXMX, Inc.	New York, NY, United States	Manufacturer	0	api.fda.gov
RemetricHealth Inc.	Allentown, PA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Rocoto Inc.	Irvine, CA, United States	Manufacturer	0	api.fda.gov
Sanusom Operating Company, Inc.	Brentwood, TN, United States	Manufacturer	0	api.fda.gov
Sechrist Industries, Inc.	Anaheim, CA, United States	Manufacturer	0	api.fda.gov
Sibel Health Inc.	Chicago, IL, United States	Manufacturer	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	Specification developer	0	api.fda.gov
Spaulding Medical, LLC	Menomonee Falls, WI, United States	Manufacturer	0	api.fda.gov
Spinal Technology, LLC	West Yarmouth, MA, United States	Specification developer	0	api.fda.gov
Standard Imaging, Inc.	Middleton, WI, United States	Manufacturer	0	api.fda.gov
Stereotaxis, Inc.	Saint Louis, MO, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Spinal Systems, LLC	Louisville, KY, United States	Specification developer	0	api.fda.gov
Stairway Interactive, LLC	Chicago, IL, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Tecan Cdmo Solutions MH, Corp.	Morgan Hill, CA, United States	Contract manufacturer	0	api.fda.gov
Thirdwayv Inc.	Irvine, CA, United States	Manufacturer	0	api.fda.gov
Tidepool Project	Palo Alto, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Tnacity Blue Ocean, Inc.	Memphis, TN, United States	Specification developer	0	api.fda.gov
Terumo BCT, Inc..	Lakewood, CO, United States	Manufacturer	0	api.fda.gov
Theator Inc.	Palo Alto, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Topcon Healthcare, Inc.	Oakland, NJ, United States	Manufacturer	0	api.fda.gov
Unika Health Inc.	Sunnyvale, CA, United States	Specification developer	0	api.fda.gov
Veris Health	Foxborough, MA, United States	Specification developer	0	api.fda.gov
Vitazi.ai, Inc.	San Diego, CA, United States	Manufacturer	0	api.fda.gov
Volk Optical Inc.	Mentor, OH, United States	Manufacturer	0	api.fda.gov
Westwood Precision LLC	Allentown, PA, United States	Contract manufacturer	0	api.fda.gov
Zimmer Surgical, Inc.	Dover, OH, United States	Manufacturer	0	api.fda.gov
ZYTO Technologies, Inc.	Lehi, UT, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Zywie, Inc.	Johns Creek, GA, United States	Manufacturer	0	api.fda.gov
eResearchTechnology, Inc.	Philadelphia, PA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
iHealth Labs, Inc.	Sunnyvale, CA, United States	Manufacturer	0	api.fda.gov
spencer Health Solutions	Morrisville, NC, United States	Specification developer	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.