Company ยท US
Northeast Scientific Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2025. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 2025 | K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) Northeast Scientific, Inc. | OWQ |
| Feb 3, 2023 | K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Northeast Scientific, Inc. | OWQ |
| Jul 1, 2022 | K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter Northeast Scientific, Inc. | QTF |
| Jun 22, 2020 | K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter Northeast Scientific, Inc. | OBJ |
| Jul 21, 2010 | K090661 | NES REPROCESSED VARICOSE VEIN RF CATHETER Northeast Scientific, Inc. | NUJ |
| Sep 7, 2007 | K060676 | NES REPROCESSED ENDOSCOPIC TROCAR Northeast Scientific, Inc. | NLM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2025 | Northeast Scientific Inc. NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including a Open, Classified |
QTF | None listed |
| Oct 2, 2025 | Northeast Scientific Inc. NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including a Open, Classified |
QTF | None listed |
| Oct 2, 2025 | Northeast Scientific Inc. NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including a Open, Classified |
QTF | None listed |
| Oct 2, 2025 | Northeast Scientific Inc. NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, inc Open, Classified |
QTF | None listed |
| Oct 2, 2025 | Northeast Scientific Inc. NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including Open, Classified |
QTF | None listed |
| Oct 2, 2025 | Northeast Scientific Inc. NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including Open, Classified |
QTF | None listed |
| Oct 2, 2025 | Northeast Scientific Inc. NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includin Open, Classified |
QTF | None listed |
| Oct 2, 2025 | Northeast Scientific Inc. NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including Open, Classified |
QTF | K220171 |
| Apr 26, 2021 | Northeast Scientific Inc. NES Reprocessed Visions PV .035 IVUS Catheter, Sterile.
For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such ves Terminated |
OWQ | None listed |