Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSURGICAL APPLIANCE INDUSTRIES, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 3960 ROSSLYN DR., CINCINNATI, OH, 45209
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1511629
- DUNS Number
- —
Catalogue (2353)
Page 47 of 48| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Truform® | NV3382BL-L | FDA UDI | Class II | Active |
| Truform® | 0808BL-2L | FDA UDI | Class II | Active |
| Truform® | NV5508WH-4L | FDA UDI | Class II | Active |
| Truform® | 0363BG-XL | FDA UDI | Class II | Active |
| Truform® | 0265BG-XL | FDA UDI | Class II | Active |
| Truform® | NV4965BL-M | FDA UDI | Class II | Active |
| Truform® | NV2263NV-S | FDA UDI | Class II | Active |
| Truform® | NV3383ND-L | FDA UDI | Class II | Active |
| Truform® | NV3374ND-S | FDA UDI | Class II | Active |
| Truform® | 1777-T | FDA UDI | Class II | Active |
| Truform® | 0965ABL-M | FDA UDI | Class II | Active |
| Truform® | 0263WH-M | FDA UDI | Class II | Active |
| Truform® | 1772PK-M | FDA UDI | Class II | Active |
| Truform® | NV5548BL-XL | FDA UDI | Class II | Active |
| Truform® | 8808BG-4L | FDA UDI | Class II | Active |
| NuVein | NV4475BL-L | FDA UDI | Class II | Active |
| Truform® | NV3373WH-L | FDA UDI | Class II | Active |
| Truform® | 1775LB-Q | FDA UDI | Class II | Active |
| Truform® | NV7715BL-L | FDA UDI | Class II | Active |
| Truform® | 0264ND-L | FDA UDI | Class II | Active |
| Truform® | 0375BL-XL | FDA UDI | Class II | Active |
| Truform® | NV7726BG-M | FDA UDI | Class II | Active |
| Truform® | NV2243CH-XL | FDA UDI | Class II | Active |
| Truform® | 8865BN-3L | FDA UDI | Class II | Active |
| Truform® | 3316BG-M | FDA UDI | Class II | Active |
| Truform® | NV4965BL-XL | FDA UDI | Class II | Active |
| Truform® | NV5545WH-M | FDA UDI | Class II | Active |
| Truform® | 1773ND-2L | FDA UDI | Class II | Active |
| Truform® | NV5568BL-XL | FDA UDI | Class II | Active |
| Truform® | NV3373CH-S | FDA UDI | Class II | Active |
| NuVein | NV3373BL-3L | FDA UDI | Class II | Active |
| NuVein | NV2218BL-L | FDA UDI | Class II | Active |
| NuVein | NV5565BG-S | FDA UDI | Class II | Active |
| NuVein | NV2233BL-M | FDA UDI | Class II | Active |
| NuVein | NV3372BL-XL | FDA UDI | Class II | Active |
| NuVein | NV3373BL-M | FDA UDI | Class II | Active |
| NuVein | NV2273WH-M | FDA UDI | Class II | Active |
| NuVein | NV2263WH-XL | FDA UDI | Class II | Active |
| NuVein | NV2273BL-S | FDA UDI | Class II | Active |
| NuVein | NV2243WH-M | FDA UDI | Class II | Active |
| NuVein | NV5575BL-L | FDA UDI | Class II | Active |
| NuVein | NV2233WH-XL | FDA UDI | Class II | Active |
| NuVein | NV2233BL-XL | FDA UDI | Class II | Active |
| NuVein | NV2263BL-M | FDA UDI | Class II | Active |
| Cruciform Anterior Spinal Hyperexten. O | K812401 | FDA 510(k) | Class I | Active |
| External Breast Prosthesis | K813416 | FDA 510(k) | Class I | Active |
| Lumbo-Sacral Flexion Orthosis | K811494 | FDA 510(k) | Class I | Active |
| Neoprene Knee Support | K812423 | FDA 510(k) | Class I | Active |
| Ankle-Foot Cast/Splint | K811690 | FDA 510(k) | Class I | Active |
| Custom Contour Lumbosacral Orthosis | K812422 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
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 |
|---|---|---|---|---|
| Oct 7, 2011 | Z-0392-2012 | — | terminated | During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s |
| Oct 7, 2011 | Z-0391-2012 | — | terminated | During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s |