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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
- —
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1511629
- DUNS Number
- —
Catalogue (2353)
Page 48 of 48| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Truncal Orthosis | K821682 | FDA 510(k) | Class I | Active |
| Truform Ready-To-Wear Compression Arm Sleece Truform Ready-To-Wear Compression Gauntlet | K121106 | FDA 510(k) | Class II | Active |
| Cylinder Knee Cast/Splint | K811689 | FDA 510(k) | Class I | Active |
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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 |