Data / Medical devices / Device, Thermal Ablation, Endometrial
Device, Thermal Ablation, Endometrial (MNB): 13 FDA-registered makers in 2 countries
13 establishments in 2 countries are registered with the FDA to make Device, Thermal Ablation, Endometrial (product code MNB, Class 3). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MNB
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Costa Rica | 2 |
Makers of Device, Thermal Ablation, Endometrial
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Axora Medical, Inc. | Sunnyvale, CA, United States | Complaint file establishment, Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Minerva Surgical, Inc. | Santa Clara, CA, United States | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Channel Medsystems | Berkeley, CA, United States | Manufacturer | 0 | 1 | 2 | 0 | api.fda.gov | |
| Hologic, Inc. | Marlborough, MA, United States | Complaint file establishment, Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Hologic Surgical Products Costa Rica, S.R.L. | El Coyol Alajuela, Costa Rica | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | Marlborough, MA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Microcube, LLC | Fremont, CA, United States | Manufacturer, Manufacturer for export | 0 | 1 | 0 | 0 | api.fda.gov | |
| Apical Instruments | Redwood City, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Santa Rosa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMC Costa Rica Division S.R.L. | El Coyol Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vonco Products, LLC | Fortville, IN, United States | Contract 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.