Northeast Scientific Inc.
FDA Regulatory Profile
Northeast Scientific Inc. appears in FDA public data with 9 recalls, 6 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0025-2026, Class II) was initiated on Aug 29, 2025. Its most recent 510(k) clearance was granted on May 12, 2025.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 6
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0025-2026 | Class II | NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES | Aug 29, 2025 |
| Z-0022-2026 | Class II | NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. | Aug 29, 2025 |
| Z-0024-2026 | Class II | NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES | Aug 29, 2025 |
| Z-0019-2026 | Class II | NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The | Aug 29, 2025 |
| Z-0018-2026 | Class II | NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NE | Aug 29, 2025 |
| Z-0023-2026 | Class II | NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES | Aug 29, 2025 |
| Z-0020-2026 | Class II | NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NE | Aug 29, 2025 |
| Z-0021-2026 | Class II | NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NE | Aug 29, 2025 |
| Z-2334-2021 | Class II | NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular mor | Apr 26, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | May 12, 2025 |
| K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Feb 3, 2023 |
| K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | Jul 1, 2022 |
| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | Jun 22, 2020 |
| K090661 | NES REPROCESSED VARICOSE VEIN RF CATHETER | Jul 21, 2010 |
| K060676 | NES REPROCESSED ENDOSCOPIC TROCAR | Sep 7, 2007 |