GZF

Death

10

Injury

2,410

Other

1

Total

2,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K243782 — StimTrial Neuromodulation System Bioventus, LLC · 2025-07-16
• K243678 — TalisMann Neuromodulation System Bioventus, LLC · 2025-07-03
• K232415 — Nalu Neurostimulation System for Peripheral Nerve Stimulation Boston Scientific Neuromodulation · 2024-08-21
• K233162 — Freedom Peripheral Nerve Stimulator (PNS) System Curonix · 2024-06-20
• K221303 — Neuspera Nuity System Neuspera Medical, Inc. · 2023-04-11
• K211965 — StimRouter Neuromodulation System Bioness, Inc. · 2022-02-23
• K202781 — Neuspera Neurostimulation System (NNS) Neuspera Medical, Inc. · 2021-08-27
• K200848 — Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit Micron Medical Corporation · 2020-08-14
• K200482 — StimRouter Neuromodulation System Bioness, Inc. · 2020-03-27
• K190047 — StimRouter Neuromodulation System Bioness, Inc. · 2019-10-31
• K191435 — IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 Nalu Medical, Inc. · 2019-09-06
• K183579 — Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits Boston Scientific Neuromodulation · 2019-03-29
• K171366 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit Stimwave Technologies Inc., Dba Stimq, LLC · 2017-08-04
• K152178 — StimQ Peripheral Nerve Stimulator (PNS) System Stimq, LLC · 2016-03-11
• K142432 — StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit Bioness, Inc. · 2015-02-20
• K000852 — RENEW NEUROSTIMULATION SYSTEM Advanced Neuromodulation Systems · 2001-01-19
• K000105 — MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), Medtronic Vascular · 2000-04-12
• K982902 — PERIPHERAL NERVE STIMULATION Medtronic Vascular · 1998-11-10
• K960631 — MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX Medtronic Vascular · 1996-05-21
• K950425 — TECOTHANE 55D Medtronic Vascular · 1995-04-19
• K925952 — MEDTRONIC MODEL 3990 PNS LEAD Medtronic Vascular · 1993-08-20
• K920567 — MODELS 3987 AND 3988 RESUME LEAD FOR PNS Medtronic Vascular · 1992-05-20
• K915540 — MODEL 3587A RESUME II LEAD Medtronic Vascular · 1992-01-22
• K904409 — MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER Medtronic Vascular · 1991-01-30