Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list ivWatch, LLC with 6 510(k) clearances. The most recent is a 510(k) clearance dated Mar 15, 2024: ivWatch® Model 400.
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.
| Date | Record | Source |
|---|---|---|
| Mar 15, 2024 | ivWatch® Model 400K233881 · PMS | 510(k) clearances |
| Aug 24, 2022 | ivWatch Model 400K222212 · PMS | 510(k) clearances |
| Jul 2, 2020 | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableK192385 · PMS | 510(k) clearances |
| Dec 22, 2016 | ivWatchK162478 · PMS | 510(k) clearances |
| Feb 11, 2016 | ivWatch Model 400K153605 · PMS | 510(k) clearances |
| Feb 13, 2015 | ivWatch Model 400K142374 · MRZ | 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
