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Sign in to claim this brandNORTHEAST SCIENTIFIC, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2142 Thomaston Ave, Waterbury, CT, 06704
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3005467144
- DUNS Number
- —
Catalogue (60)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | K220171 | FDA 510(k) | Class II | Active |
| Nes Reprocessed Varicose Vein Rf Catheter | K090661 | FDA 510(k) | Class II | Active |
| Tissue Transport Medium | K833016 | FDA 510(k) | Class I | Active |
| NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | K223026 | FDA 510(k) | Class II | Active |
| Dexsol | K883854 | FDA 510(k) | U | Active |
| Csm Medium | K854052 | FDA 510(k) | U | Active |
| NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | K200195 | FDA 510(k) | Class II | Active |
| NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | K250592 | FDA 510(k) | Class II | Active |
| NES Reprocessed RF Stylet (RFS) | K173214 | FDA 510(k) | Class II | Active |
| Nes Reprocessed Endoscopic Trocar | K060676 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
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Importers
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Authorities
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FDA Recalls (9)
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 |
|---|---|---|---|---|
| Aug 29, 2025 | Z-0025-2026 | — | open, classified | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| Aug 29, 2025 | Z-0021-2026 | — | open, classified | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| Aug 29, 2025 | Z-0024-2026 | — | open, classified | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| Aug 29, 2025 | Z-0018-2026 | — | open, classified | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| Aug 29, 2025 | Z-0019-2026 | — | open, classified | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| Aug 29, 2025 | Z-0023-2026 | — | open, classified | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| Aug 29, 2025 | Z-0022-2026 | — | open, classified | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| Aug 29, 2025 | Z-0020-2026 | — | open, classified | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| Apr 26, 2021 | Z-2334-2021 | — | terminated | 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. |