Caldera Medical, Inc.
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories5
Latest FDA decision2023-11-30
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K233500 | Benesta Tissue Removal Device | HIH | 2023-11-30 | View |
| 510(k) | K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System | OTN | 2021-11-10 | View |
| 510(k) | K192811 | BenestaTM Tissue Removal Device | HIH | 2020-10-23 | View |
| 510(k) | K192822 | Benesta Hysteroscope | HIH | 2020-09-09 | View |
| 510(k) | K193603 | Benesta Medical Sterilization Tray | KCT | 2020-07-20 | View |
| 510(k) | K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | PAH | 2020-02-07 | View |
| 510(k) | K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left | PWJ | 2018-05-04 | View |
| 510(k) | K162201 | Desara TV, Desara Blue TV | OTN | 2017-01-11 | View |
No matching devices.