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Boston Scientific Neuromodulation Corporation

18 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD K recall (Z-2879-2026)Boston Scientific Neuromodulation Corporation2026-08-05
Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035 recall (Z-2694-2026)Boston Scientific Neuromodulation Corporation2026-07-08
Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 2 recall (Z-2402-2026)Boston Scientific Neuromodulation Corporation2026-06-11
Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.01 recall (Z-2403-2026)Boston Scientific Neuromodulation Corporation2026-06-11
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 recall (Z-2404-2026)Boston Scientific Neuromodulation Corporation2026-06-11
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632- recall (Z-2558-2025)Boston Scientific Neuromodulation Corporation2025-09-12
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 008846620 recall (Z-2485-2025)Boston Scientific Neuromodulation Corporation2025-09-02
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Com recall (Z-2340-2025)Boston Scientific Neuromodulation Corporation2025-08-19
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT recall (Z-2617-2024)Boston Scientific Neuromodulation Corporation2024-08-14
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, R recall (Z-1890-2024)Boston Scientific Neuromodulation Corporation2024-05-24
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used recall (Z-1972-2023)Boston Scientific Neuromodulation Corporation2023-06-15
Superion Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-981 recall (Z-0230-2023)Boston Scientific Neuromodulation Corporation2022-11-14
Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for recall (Z-1694-2020)Boston Scientific Neuromodulation Corporation2020-04-10
Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indi recall (Z-1695-2020)Boston Scientific Neuromodulation Corporation2020-04-10
Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for recall (Z-1696-2020)Boston Scientific Neuromodulation Corporation2020-04-10
Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indi recall (Z-1697-2020)Boston Scientific Neuromodulation Corporation2020-04-10
Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for us recall (Z-1698-2020)Boston Scientific Neuromodulation Corporation2020-04-10
Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4 recall (Z-1409-2010)Boston Scientific Neuromodulation Corporation2010-04-16

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