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Sign in to claim this brandINSIGHTRA MEDICAL, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2543 Madison St, Clarksville, TN, 37043
- Website
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003945344
- DUNS Number
- —
Catalogue (59)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| owerPumpTM dp System Interface Cable, Type 2 | 941027G | FDA UDI | Class II | Active |
| Freedom - ProFlor Inguinal Hernia Implant | FIHR 25mmE | FDA UDI | Class II | Active |
| Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep Tray | K924958 | FDA 510(k) | Class I | Active |
| Kittner Dissector/Peanut/Cherry/Stick/Triangle Sponge/Gauze Rosebud | K940904 | FDA 510(k) | U | Active |
| Freedom Inguinal Hernia Implant | K113552 | FDA 510(k) | Class II | Active |
| Tonsil Sponge, Gauze Dissector, Cylindrical Sponges | K940903 | FDA 510(k) | Class I | Active |
| Freedom Inguinal Hernia Repair Implant-25mm/40mm/40mm With Extended Disk | K140967 | FDA 510(k) | Class II | Active |
| Ultra Iabp Catheter Kit, Models Imu7f-40, Imu7f-35, Imu7f-30, Imu7f-25, Imu7f-20 | K082746 | FDA 510(k) | Class II | Active |
| Insightra Freedom Ventral Hernia Repair System | K142192 | FDA 510(k) | Class II | Active |
Related Companies
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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 |
|---|---|---|---|---|
| Jul 19, 2025 | Z-2298-2025 | — | terminated | Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training. |