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Sign in to claim this brandSILEX MEDICAL, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 24 Robert Porter Rd Ste B, SOUTHINGTON, CT, 06489
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3005110411
- DUNS Number
- 362145604
Catalogue (311)
Page 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Signature | 5861000 | FDA UDI | Class II | Active |
| Silex | ONX-1067L | FDA UDI | Class II | Active |
| Signature | 5881044 | FDA UDI | Class II | Active |
| Silex | PLT-1067 | FDA UDI | Class II | Active |
| Silex | PLT-1045 | FDA UDI | Class II | Active |
| Signature | 5872130 | FDA UDI | Class II | Active |
| Signature | 5851069 | FDA UDI | Class II | Active |
| Silex | PLT-1024 | FDA UDI | Class II | Active |
| Signature | 5851035 | FDA UDI | Class II | Active |
| Signature | 5881003-45 | FDA UDI | Class II | Active |
| Silex | EZL-1044 | FDA UDI | Class II | Active |
| Signature | 5864110-45 | FDA UDI | Class II | Active |
| Silex | ONX-1067 | FDA UDI | Class II | Active |
| Silex | EZL-1067-45 | FDA UDI | Class II | Active |
| Signature | 5851037 | FDA UDI | Class II | Active |
| Signature | 5881088-45 | FDA UDI | Class II | Active |
| Signature | 5851066-45 | FDA UDI | Class II | Active |
| Signature | 5851092-45 | FDA UDI | Class II | Active |
| Signature | 5851034 | FDA UDI | Class II | Active |
| Silex | EZL-1012 | FDA UDI | Class II | Active |
| Signature | 5881092-45 | FDA UDI | Class II | Active |
| Signature | 5881056-45 | FDA UDI | Class II | Active |
| Silex | PLT-1052L | FDA UDI | Class II | Active |
| Silex | EZL-1091 | FDA UDI | Class II | Active |
| Silex | ONX-1063 | FDA UDI | Class II | Active |
| Signature | 5851089-45 | FDA UDI | Class II | Active |
| Signature | 5881007-45 | FDA UDI | Class II | Active |
| Silex | EZL-1006 | FDA UDI | Class II | Active |
| Silex | EZL-1066 | FDA UDI | Class II | Active |
| Signature | 5851064 | FDA UDI | Class II | Active |
| Silex | EZL-1006-45 | FDA UDI | Class II | Active |
| Signature | 5860030 | FDA UDI | Class II | Active |
| Signature | 5851037 | FDA UDI | Class II | Active |
| Signature | 5862000-45 | FDA UDI | Class II | Active |
| Signature | 5881032 | FDA UDI | Class II | Active |
| Signature | 5851078-45 | FDA UDI | Class II | Active |
| Signature | 5851093 | FDA UDI | Class II | Active |
| Silex | EZL-1087-45 | FDA UDI | Class II | Active |
| Signature | 5862020 | FDA UDI | Class II | Active |
| Silex | ONX-1037L | FDA UDI | Class II | Active |
| Silex | EZL-1005 | FDA UDI | Class II | Active |
| Silex | EZL-1078 | FDA UDI | Class II | Active |
| Silex | PLT-1093L-45 | FDA UDI | Class II | Active |
| Signature | 5881012-45 | FDA UDI | Class II | Active |
| Silex | ONX-1056 | FDA UDI | Class II | Active |
| Silex | ONX-1069L | FDA UDI | Class II | Active |
| Signature | 5863020 | FDA UDI | Class II | Active |
| Signature | 5851079 | FDA UDI | Class II | Active |
| Signature | 5851006-45 | FDA UDI | Class II | Active |
| Silex | PLT-1079L | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
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Importers
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Notified Bodies
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Authorities
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FDA Recalls (8)
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 |
|---|---|---|---|---|
| Jan 9, 2024 | Z-1894-2025 | — | open, classified | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. |
| Jan 9, 2024 | Z-1898-2025 | — | open, classified | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. |
| Jan 9, 2024 | Z-1895-2025 | — | open, classified | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. |
| Jan 9, 2024 | Z-1893-2025 | — | open, classified | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. |
| Jan 9, 2024 | Z-1900-2025 | — | open, classified | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. |
| Jan 9, 2024 | Z-1899-2025 | — | open, classified | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. |
| Jan 9, 2024 | Z-1896-2025 | — | open, classified | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. |
| Jan 9, 2024 | Z-1897-2025 | — | open, classified | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. |