Data / Medical devices / Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue / United States
FDA-registered makers of Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue (product code OCL). 6 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
- Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- Product code
- OCL
- Country
- United States
Makers of Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Atricure, Inc. | Mason, OH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 18 | July 24, 2025 | 0 | 4 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer for export, Specification developer | 12 | December 22, 2022 | 0 | 2 | 0 | api.fda.gov |
| Medtronic Grand Rapids | Grand Rapids, MI, United States | Manufacturer | 5 | June 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. (Minneapolis, MN 55447) | Minneapolis, MN, United States | Manufacturer | 2 | April 1, 2013 | 0 | 1 | 0 | api.fda.gov |
| Covidien | Boulder, CO, United States | Manufacturer | 1 | December 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 1 | December 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Apical Instruments | Redwood City, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CEA Medical Manufacturing, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vesta | Franklin, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Varian Medical Systems, Inc | Austin, TX, United States | Manufacturer | 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.