Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Caldera Medical with 24 510(k) clearances. The most recent is a 510(k) clearance dated Nov 30, 2023: Benesta Tissue Removal Device.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 30, 2023 | Benesta Tissue Removal DeviceK233500 · HIH | 510(k) clearances |
| Nov 10, 2021 | 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 SystemK211975 · OTN | 510(k) clearances |
| Oct 23, 2020 | BenestaTM Tissue Removal DeviceK192811 · HIH | 510(k) clearances |
| Sep 9, 2020 | Benesta HysteroscopeK192822 · HIH | 510(k) clearances |
| Jul 20, 2020 | Benesta Medical Sterilization TrayK193603 · KCT | 510(k) clearances |
| Feb 7, 2020 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackK191416 · PAH | 510(k) clearances |
| May 4, 2018 | 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, LeftK172614 · PWJ | 510(k) clearances |
| Jan 11, 2017 | Desara TV, Desara Blue TVK162201 · OTN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
