St. Louis, MO, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | Class II | Cardiovascular | 1 | 2021-01-05 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-03-04 | Class II | Ongoing | Z-1631-2026 | Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: E… | — | Product labeling includes a fetal indication for use that is not cleared under its 510(k). |