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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 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FDP Probe | FDP-10 | FDA UDI | Class II | Unknown |
| BiDop 7 probe | ST5M05S8A | FDA UDI | Class II | Active |
| Ct | CT-4 | FDA UDI | Class I | Active |
| Es101ex | ES101EX-2 | FDA UDI | Class II | Unknown |
| Pencil probe | P5M05S8A | FDA UDI | Class II | Active |
| Hd-307 | HD-307-20 | FDA UDI | Class II | Active |
| Bt5m05s8a | BT5M05S8A | FDA UDI | Class II | Active |
| Bt2m20s8c | BT2M20S8C | FDA UDI | Class II | Active |
| Hd-307 | HD-307-10 | FDA UDI | Class II | Active |
| T10m5s8c | T10M5S8C | FDA UDI | Class II | Active |
| F8m10s8a | F8M10S8A | FDA UDI | Class II | Unknown |
| NP Probe | NP20M1S8A | FDA UDI | Class II | Active |
| T2m20s8c | T2M20S8C | FDA UDI | Class II | Active |
| Ct | CT-6 | FDA UDI | Class I | Active |
| Adaptor | BDP20MS8 | FDA UDI | Class II | Active |
| CRP Probe | CRP-20H | FDA UDI | Class II | Active |
| Acp-08 | ACP-08 | FDA UDI | Class II | Active |
| ES100X MiniDop | ES100X | FDA UDI | Class II | Active |
| BiDop 7 probe | ST10M5S8A | FDA UDI | Class II | Active |
| Bt5m05s8c | BT5M05S8C | FDA UDI | Class II | Active |
| Smartdop 30EX | Smartdop 30EX | FDA UDI | Class II | Active |
| NRP Probe | NRP-20H | FDA UDI | Class II | Active |
| Pencil probe | P8M05S8A | FDA UDI | Class II | Active |
| Adaptor | DP10MS8 | FDA UDI | Class II | Active |
| Es100vx | ES100VX | FDA UDI | Class II | Active |
| BiDop 7 probe | ST8M05S8C | FDA UDI | Class II | Active |
| Vdp-10a | VDP-10A | FDA UDI | Class II | Active |
| Adaptor | DP08MS8 | FDA UDI | Class II | Active |
| BiDop 7 probe | ST5M05S8C | FDA UDI | Class II | Active |
| Smart-V-Link | Smart-V-Link | FDA UDI | Class II | Active |
| Pencil probe | PP10M5N5A | FDA UDI | Class II | Active |
| HP Probe | HP10M2N5AF | FDA UDI | Class II | Active |
| BiDop 7 probe | ST2M25S8C | FDA UDI | Class II | Active |
| Ct | CT-2 | FDA UDI | Class I | Active |
| Pencil probe | BP8M05S8A | FDA UDI | Class II | Active |
| Pencil probe | BP5M05S8A | FDA UDI | Class II | Active |
| HP Probe | HP20M1N5AF | FDA UDI | Class II | Active |
| CRP Probe | CRP-10H | FDA UDI | Class II | Active |
| Bf2m20s8a | BF2M20S8A | FDA UDI | Class II | Active |
| T8m05s8c | T8M05S8C | FDA UDI | Class II | Active |
| Smartdop XT6 | K153762 | FDA 510(k) | Class II | Active |
| B Smart Model 1 | K961817 | FDA 510(k) | Class II | Active |
| Valvulotome By Koven | K080178 | FDA 510(k) | Class II | Active |
| Smartdop 30 Bi-Directional Blood Flow Detector | K942613 | FDA 510(k) | Class II | Active |
| Smartdop 45 Vascular Doppler | K050601 | FDA 510(k) | Class II | Active |
| Echo Sounder, Es-102ex | K023143 | FDA 510(k) | Class II | Active |
| Bidirectional Doppler W/Waveform Display | K954397 | FDA 510(k) | Class II | Active |
| Bi-Directional Doppler Volume Flowmeter, Model Dvm-4300 & 4300t | K010452 | FDA 510(k) | Class II | Active |
| Tubing Blood Flow Meter Model Number Hd-800 | K982986 | FDA 510(k) | Class II | Active |
| Echo Sounder Ex-101ex 8 Mhz | K031931 | FDA 510(k) | Class II | 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). |