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Northeast Scientific Inc.

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
6
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0025-2026Class IINES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NESAugust 29, 2025
Z-0018-2026Class IINES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NEAugust 29, 2025
Z-0023-2026Class IINES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NESAugust 29, 2025
Z-0019-2026Class IINES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. TheAugust 29, 2025
Z-0020-2026Class IINES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NEAugust 29, 2025
Z-0021-2026Class IINES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NEAugust 29, 2025
Z-0024-2026Class IINES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NESAugust 29, 2025
Z-0022-2026Class IINES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. August 29, 2025
Z-2334-2021Class IINES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morApril 26, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)May 12, 2025
K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterFebruary 3, 2023
K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterJuly 1, 2022
K200195NES Reprocessed Visions PV .014P RX Digital IVUS CatheterJune 22, 2020
K090661NES REPROCESSED VARICOSE VEIN RF CATHETERJuly 21, 2010
K060676NES REPROCESSED ENDOSCOPIC TROCARSeptember 7, 2007