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Sign in to claim this brandEPIMED INTERNATIONAL, INC.
United States·US-MF-000010774
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 13958, Diplomat Drive, Farmers Branch, United States
- Website
- epimed.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Preston Frasier
- EUDAMED SRN
- US-MF-000010774
- FDA FEI Number
- 1316297
- DUNS Number
- —
Catalogue (191)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Epimed | 170-2124 | FDA UDI | Class II | Unknown |
| Epimed | 196-3018 | FDA UDI | Class II | Active |
| Epimed | 261-2015 | FDA UDI | Class II | Unknown |
| Epimed | 260-2210 | FDA UDI | Class II | Unknown |
| Epimed | 410-166H | FDA UDI | Class II | Active |
| Epimed | 260-2010 | FDA UDI | Class II | Unknown |
| Epimed | 260-2015 | FDA UDI | Class II | Unknown |
| Epimed | 410-166T | FDA UDI | Class II | Active |
| Epimed | 410-186H | FDA UDI | Class II | Active |
| Epimed | 263-2215 | FDA UDI | Class II | Unknown |
| Epimed | 410-146H | FDA UDI | Class II | Active |
| Epimed | 261-2208 | FDA UDI | Class II | Unknown |
| Epimed | 164-1936T | FDA UDI | Class II | Unknown |
| Epimed | 174-2024 | FDA UDI | Class II | Unknown |
| Epimed | 287-2215 | FDA UDI | Class II | Unknown |
| Epimed | 268-2010 | FDA UDI | Class II | Unknown |
| Epimed | 116-2020 | FDA UDI | Class II | Active |
| Epimed | 411-CPST | FDA UDI | Class II | Active |
| Epimed | 263-2010 | FDA UDI | Class II | Unknown |
| Epimed | 300-1815 | FDA UDI | Class II | Active |
| Epimed | 168-2014 | FDA UDI | Class II | Active |
| Epimed | 264-2208 | FDA UDI | Class II | Unknown |
| Epimed | 265-2010 | FDA UDI | Class II | Unknown |
| Epimed | 410-163H | FDA UDI | Class II | Active |
| Epimed | 174-1924 | FDA UDI | Class II | Unknown |
| Epimed | 412-CCET | FDA UDI | Class II | Active |
| Epimed | 1911-419 | FDA UDI | Class II | Active |
| Epimed | 155-1520 | FDA UDI | Class II | Active |
| Epimed | 410-156P | FDA UDI | Class II | Active |
| Epimed | 116-2230 | FDA UDI | Class II | Active |
| Epimed | 265-2015 | FDA UDI | Class II | Unknown |
| Epimed | 260-2215 | FDA UDI | Class II | Unknown |
| Epimed | 189-2260 | FDA UDI | Class II | Unknown |
| Epimed | 154-1924 | FDA UDI | Class II | Unknown |
| Epimed | 156-2136 | FDA UDI | Class II | Unknown |
| Epimed | 220-2010 | FDA UDI | Class II | Unknown |
| Extension Set, Models 1911-512 | K020926 | FDA 510(k) | Class II | Active |
| Racz Neurostat RF Generator | K232632 | FDA 510(k) | Class II | Active |
| Rf Introduction Cannula | K041021 | FDA 510(k) | Class II | Active |
| Feth-R-Kath | K981329 | FDA 510(k) | Class II | Active |
| Versa-Kath Epidural Catheter, Model 156-2124 | K023140 | FDA 510(k) | Class II | Active |
| Rulo Radiofrequency Lesion Probe | K190256 | FDA 510(k) | Class II | Active |
| Spirol Block (19 Ga. Open End Models), (20 Ga. Open End Models), (19 Ga. Closed End Models), (20 Ga. Closed End Models) | K133316 | FDA 510(k) | Class II | Active |
| Stingray Epidural Catheter Connector | K051171 | FDA 510(k) | Class II | Active |
| Tuohy Epidural Needle | K030562 | FDA 510(k) | Class II | Active |
| Percutaneous Introducer | K200624 | FDA 510(k) | Class II | Active |
| Rk Epidural Needle | K072005 | FDA 510(k) | Class II | Active |
| Flexible Introducer Cannula, Model 135-1837 | K051860 | FDA 510(k) | Class II | Active |
| Rx Epidural Needle | K053318 | FDA 510(k) | Class II | Active |
| Pencil Point Needle | K041843 | FDA 510(k) | Class II | Active |
Related Companies
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Importers
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Notified Bodies
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Authorities
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FDA Recalls (11)
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 |
|---|---|---|---|---|
| Feb 1, 2021 | Z-1276-2021 | — | terminated | Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off |
| Feb 21, 2020 | Z-1849-2020 | — | terminated | Incorrect expiration date on introduction cannula packaging. |
| Feb 21, 2020 | Z-1850-2020 | — | terminated | Incorrect expiration date on introduction cannula packaging. |
| Jun 18, 2019 | Z-2068-2019 | — | terminated | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included. |
| Jun 18, 2019 | Z-2069-2019 | — | terminated | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included. |
| Dec 28, 2017 | Z-2313-2021 | — | completed | Potential for stylet to protrude from the distal end of the catheter |
| Dec 28, 2017 | Z-2312-2021 | — | completed | Potential for stylet to protrude from the distal end of the catheter |
| Jul 24, 2017 | Z-0087-2018 | — | terminated | Potential for partially incomplete seal of product, impacting sterility. |
| Jul 24, 2017 | Z-0088-2018 | — | terminated | Potential for partially incomplete seal of product, impacting sterility. |
| Jul 24, 2017 | Z-0089-2018 | — | terminated | Potential for partially incomplete seal of product, impacting sterility. |
| Apr 22, 2016 | Z-0086-2017 | — | terminated | There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention. |