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 its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list ZetrOZ Systems, LLC with 5 510(k) clearances. The most recent is a 510(k) clearance dated Apr 28, 2026: SAM 3.0 Multi-Hour Continuous Ultrasound 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.
| Apr 28, 2026 | SAM 3.0 Multi-Hour Continuous Ultrasound DeviceK260076 · PFW | 510(k) clearances |
| Oct 25, 2023 | sam CS Long Duration Ultrasound DeviceK233210 · PFW | 510(k) clearances |
| Jun 23, 2023 | sam 2.0 Long Ultrasound DeviceK223019 · PFW | 510(k) clearances |
| Aug 18, 2021 | sam X1 Long Duration Ultrasound DeviceK211513 · PFW | 510(k) clearances |
| Mar 6, 2020 | sam 2.0 Long Duration Ultrasound SystemK191568 · PFW | 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
