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Sign in to claim this brandKoven Technology, Inc.
United States·US-MF-000000948
Last updated September 17, 2026
About
Koven Technology provides vascular Dopplers & surgical Dopplers for peripheral arterial disease assessment and intraoperative vascular and cardiovascular procedures.
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 625, 625 Maryville Centre Dr., St. Louis, United States
- Website
- www.koven.com
- —
- —
- [email protected]
- Phone
- +1 314 542 2101
- PRRC Contact
- Heather Bell
- EUDAMED SRN
- US-MF-000000948
- FDA FEI Number
- 1937397
- DUNS Number
- —
Catalogue (111)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Model Km-25 | K951449 | FDA 510(k) | Class II | Active |
| Reusable Cw Doppler Probes: Models P8m05s8a, P8m05n5a, & Lcw-8 | K934638 | FDA 510(k) | Class II | Active |
| Smartdop Xt | K131623 | FDA 510(k) | Class II | Active |
| Echo Sounder, Single-Handed, Model Es-101ex | K031504 | FDA 510(k) | Class II | Active |
| Fast Sphyg by Koven | K143332 | FDA 510(k) | Class II | Active |
| Pw Doppler Vascular Probes | K935994 | FDA 510(k) | Class II | Active |
| V-Link 3.2 For Windows | K963274 | FDA 510(k) | Class II | Active |
| Bidop 7 | K201114 | FDA 510(k) | Class II | Active |
| Single Use Doppler Probe, NDP-10 | NDP-10 | EUDAMEDFDA UDI | Class IIa | Active |
| Single Use Doppler Probe, NDP-20 | NDP-20 | EUDAMEDFDA UDI | Class IIa | Active |
| Single Use Doppler Probe, VDP-8 | VDP-8 | EUDAMEDFDA UDI | Class IIa | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 4, 2026 | Z-1631-2026 | — | open, classified | Product labeling includes a fetal indication for use that is not cleared under its 510(k). |