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Northeast Scientific Inc.

8 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. recall (Z-0018-2026)Northeast Scientific Inc.2025-10-02
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. recall (Z-0019-2026)Northeast Scientific Inc.2025-10-02
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. recall (Z-0020-2026)Northeast Scientific Inc.2025-10-02
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. recall (Z-0021-2026)Northeast Scientific Inc.2025-10-02
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-4 recall (Z-0022-2026)Northeast Scientific Inc.2025-10-02
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. recall (Z-0023-2026)Northeast Scientific Inc.2025-10-02
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. recall (Z-0024-2026)Northeast Scientific Inc.2025-10-02
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. recall (Z-0025-2026)Northeast Scientific Inc.2025-10-02

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Every clearance here is in the API, with alerts when new ones post.