Data / Medical devices / Software For Diagnosis/Treatment / United States
FDA-registered makers of Software For Diagnosis/Treatment in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Software For Diagnosis/Treatment (product code OSN). 4 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
- Software For Diagnosis/Treatment
- Product code
- OSN
- Country
- United States
Makers of Software For Diagnosis/Treatment in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 1 | August 13, 2018 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 1 | August 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 1 | August 25, 2022 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 1 | August 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| B & J Medical LLC | Kendallville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam West LLC | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Medical LLC | Memphis, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopediatrics, Corp | Warsaw, IN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Edge Surgical Products Company | Sault Sainte Marie, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterilmed, Inc. | Plymouth, MN, United States | Reprocessor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 0 | 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.