Data / Medical devices / Low Energy Direct Current Thermal Ablation System / United States
FDA-registered makers of Low Energy Direct Current Thermal Ablation System in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Low Energy Direct Current Thermal Ablation System (product code OAB). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Low Energy Direct Current Thermal Ablation System
- Product code
- OAB
- Country
- United States
Makers of Low Energy Direct Current Thermal Ablation System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 4 | March 24, 2026 | 0 | 3 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 4 | March 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Angiodynamics, Inc | Glens Falls, NY, United States | Manufacturer | 3 | December 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Galvanize Therapeutics | Redwood City, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | May 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Canady Biotechnology LLC | Takoma Park, MD, United States | Manufacturer | 1 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Meddux Development Corporation LLC | Boulder, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RBC Development LLC dba RBC Medical Innovations dba Vantage MedTech | Olathe, KS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics U.S., LLC | Salt Lake City, UT, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.