Poiesis Medical, LLC
Poiesis Medical, LLC has 0 FDA recalls, 5 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Oct 30, 2024 · VAI
- Latest 510(k)
- Mar 29, 2018
Reviewing Poiesis Medical, LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or get Poiesis Medical, LLC's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 1 | Oct 4, 2026 | Not stated | Current |
| Inspections | 5 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 30, 2024 | Jupiter, FL | Devices | Voluntary Action Indicated (VAI) | 3009425008 |
| Jan 30, 2019 | Jupiter, FL | Devices | No Action Indicated (NAI) | 3009425008 |
| Aug 23, 2018 | Jupiter, FL | Devices | Voluntary Action Indicated (VAI) | 3009425008 |
| May 22, 2017 | Jupiter, FL | Devices | Voluntary Action Indicated (VAI) | 3009425008 |
| Feb 12, 2013 | Jupiter, FL | Devices | Voluntary Action Indicated (VAI) | 3009425008 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K173533 | Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter | Mar 29, 2018 |