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NORTHEAST SCIENTIFIC, INC.

Last updated September 17, 2026

Information

Country: US
Address: 2142 Thomaston Ave, Waterbury, CT, 06704
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3005467144
DUNS Number: —

Catalogue (60)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter	R-85900P	FDA UDI	Class II	Active
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter	R-410-152	FDA UDI	Class II	Unknown
Vein Ablation Pack	700005	FDA UDI	Class I	Active
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter	R-85900P	FDA UDI	Class II	Active
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter	R-414-159	FDA UDI	Class II	Active
NES Reprocessed Varicose Vein RF Catheter	CF7-7-100	FDA UDI	Class II	Active
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter	R-410-154	FDA UDI	Class II	Active
NES Reprocessed Varicose Vein RF Catheter	CF7-7-100	FDA UDI	Class II	Active
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter	R-410-154	FDA UDI	Class II	Active
NES Reprocessed Visions PV .035 Digital IVUS Catheter	R-88901	FDA UDI	Class II	Active
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter	R-417-156	FDA UDI	Class II	Active
NES Reprocessed Visions PV .018 Digital IVUS Catheter	R-86700	FDA UDI	Class II	Active
NES Reprocessed Eagle Eye Platinum Short Tip Stryker	R-S85900PST	FDA UDI	Class II	Active
NES Reprocessed Varicose Vein RF Catheter	CF7-7-60	FDA UDI	Class II	Active
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter	R-417-152	FDA UDI	Class II	Active
NES Reprocessed RF Stylet (RFS)	R-RFS2-6-12	FDA UDI	Class II	Active
NES Reprocessed .035 Stryker Catheter	R-S88901	FDA UDI	Class II	Active
NES Reprocessed Varicose Vein RF Catheter	CF7-3-60	FDA UDI	Class II	Active
NES Reprocessed .014 Stryker Catheter	R-S014R	FDA UDI	Class II	Active
Vein Ablation Pack	700004	FDA UDI	Class I	Active
EsoSure	100001	FDA UDI	Class I	Active
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter	R-420-006	FDA UDI	Class II	Active
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter	R-410-154	FDA UDI	Class II	Unknown
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short Tip	R-85900PST	FDA UDI	Class II	Active
NES Reprocessed Varicose Vein RF Catheter	CF7-3-60	FDA UDI	Class II	Active
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter	R-420-006	FDA UDI	Class II	Active
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter	R-410-152	FDA UDI	Class II	Active
NES Reprocessed RF Stylet (RFS)	R-RFS2-6-12	FDA UDI	Class II	Active
NES Reprocessed Visions PV .035 Digital IVUS Catheter	R-88901	FDA UDI	Class II	Active
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter	R-420-159	FDA UDI	Class II	Active
NES Reprocessed RF Stylet (RFS)	R-RFS2-6-12	FDA UDI	Class II	Unknown
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter	R-014R	FDA UDI	Class II	Unknown
EsoSure	100001	FDA UDI	Class I	Active
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter	R-014R	FDA UDI	Class II	Active
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter	R-414-151	FDA UDI	Class II	Active
NES Reprocessed Eagle Eye Platinum Long Tip Stryker	R-S85900P	FDA UDI	Class II	Active
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter	R-417-152	FDA UDI	Class II	Active
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter	R-420-159	FDA UDI	Class II	Active
NES Reprocessed Visions PV .035 Digital IVUS Catheter	R-88901	FDA UDI	Class II	Unknown
NES Reprocessed Eagle Eye Platinum Short Tip Stryker	R-S85900PST	FDA UDI	Class II	Active
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter	R-417-156	FDA UDI	Class II	Active
NES Reprocessed .035 Stryker Catheter	R-S88901	FDA UDI	Class II	Active
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter	R-414-151	FDA UDI	Class II	Active
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter	R-414-159	FDA UDI	Class II	Active
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter	R-014R	FDA UDI	Class II	Active
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter	R-410-152	FDA UDI	Class II	Active
NES Reprocessed Varicose Vein RF Catheter	CF7-7-60	FDA UDI	Class II	Active
NES Reprocessed .014 Stryker Catheter	R-S014R	FDA UDI	Class II	Active
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short Tip	R-85900PST	FDA UDI	Class II	Active
NES Reprocessed Eagle Eye Platinum Long Tip Stryker	R-S85900P	FDA UDI	Class II	Active

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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.