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Sign in to claim this brandSILEX MEDICAL, LLC
US
Last updated September 17, 2026
What SILEX MEDICAL, LLC makes
Silex Medical, LLC manufactures reusable rigid endoscopic tissue manipulation forceps and reusable endoscopic electrosurgical handpieces or electrodes with monopolar functionality.
These devices are classified as Class II medical devices and are listed in the FDA's Unique Device Identification (fda_udi) registry. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Silex Medical, LLC manufacture?
Silex Medical, LLC manufactures reusable rigid endoscopic tissue manipulation forceps and reusable endoscopic electrosurgical handpieces or electrodes with monopolar functionality, as stated in the device data summary.
Where is Silex Medical, LLC based?
Silex Medical, LLC is based in the United States, as indicated by the COUNTRY field in the device data.
Which regulatory registry lists Silex Medical, LLC's devices?
Silex Medical, LLC's devices are listed in the FDA's Unique Device Identification (fda_udi) registry, as specified in the LISTED IN field of the device data.
How are Silex Medical, LLC's devices classified?
Silex Medical, LLC's devices are classified as Class II medical devices, as stated in the DEVICE CLASSES field of the device data.
AI-generated from registry data and not verified by a human reviewer.
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 6 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Signature | 5861020-45 | FDA UDI | Class II | Active |
| Silex | EZL-1032-45 | FDA UDI | Class II | Active |
| Signature | 5881056 | FDA UDI | Class II | Active |
| Silex | PLT-1051L-45 | FDA UDI | Class II | Active |
| Signature | 5863000 | FDA UDI | Class II | Active |
| Silex | EZL-1001-45 | FDA UDI | Class II | Active |
| Silex | EZL-1005-45 | FDA UDI | Class II | Active |
| Signature | 5864000 | FDA UDI | Class II | Active |
| Silex | PLT-1028L | FDA UDI | Class II | Active |
| Silex | PLT-2020 | FDA UDI | Class II | Active |
| Silex | EZL-1012-45 | FDA UDI | Class II | Active |
| Silex | PLT-1089 | FDA UDI | Class II | Active |
| Signature | 5851089 | FDA UDI | Class II | Active |
| Silex | EZL-1028 | FDA UDI | Class II | Active |
| Signature | 5851053-45 | FDA UDI | Class II | Active |
| Silex | ONX-1053L | FDA UDI | Class II | Active |
| Signature | 5881069-45 | FDA UDI | Class II | Active |
| Signature | 5860040 | FDA UDI | Class II | Active |
| Signature | 5851071-45 | FDA UDI | Class II | Active |
| Silex | PLT-1052L-45 | FDA UDI | Class II | Active |
| Signature | 5863030-45 | FDA UDI | Class II | Active |
| Silex | EZL-1050 | FDA UDI | Class II | Unknown |
| Silex | EZL-1050-45 | FDA UDI | Class II | Unknown |
| Signature | 5851052-45 | FDA UDI | Class II | Active |
| Signature | 5860040-45 | FDA UDI | Class II | Active |
| Signature | 5851018 | FDA UDI | Class II | Active |
| Silex | EZL-1069 | FDA UDI | Class II | Active |
| Silex | EZL-1052 | FDA UDI | Class II | Active |
| Silex | EZL-1002 | FDA UDI | Class II | Active |
| Signature | 5861020 | FDA UDI | Class II | Active |
| Signature | 5881066-45 | FDA UDI | Class II | Active |
| Signature | 5881063-45 | FDA UDI | Class II | Active |
| Silex | PLT-1051 | FDA UDI | Class II | Active |
| Signature | 5881067-45 | FDA UDI | Class II | Active |
| Silex | PLT-1067L | FDA UDI | Class II | Active |
| Signature | 5851075 | FDA UDI | Class II | Active |
| Signature | 5860020 | FDA UDI | Class II | Active |
| Signature | 5851091 | FDA UDI | Class II | Active |
| Signature | 5851045-45 | FDA UDI | Class II | Active |
| Silex | EZL-1053 | FDA UDI | Class II | Active |
| Signature | 5881051-45 | FDA UDI | Class II | Active |
| Silex | EZL-1035 | FDA UDI | Class II | Active |
| Signature | 5881045-45 | FDA UDI | Class II | Active |
| Signature | 5863050 | FDA UDI | Class II | Active |
| Signature | 5881088 | FDA UDI | Class II | Active |
| Silex | ONX-2006 | FDA UDI | Class II | Active |
| Signature | 5881034-45 | FDA UDI | Class II | Active |
| Signature | 5881050-45 | FDA UDI | Class II | Active |
| Signature | 5862030 | FDA UDI | Class II | Active |
| Signature | 5862100 | FDA UDI | Class II | 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 (8)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
There are 8 recall records for SILEX MEDICAL, LLC, all initiated on 2024-01-09. The statuses of these recalls are recorded as open and classified. The reason given for the recalls is that 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.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| 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. |