Stimulator, Nerve, Battery-powered
Anesthesiology · 21 CFR 868.2775
Recent MDR events
31 adverse event reports on file
- MULTISTIM SENSORJul 21, 2026InjuryPajunk Gmbh Medizintechnologie9611612-2026-00019
- PERIPHERAL NERVE STIMULATOROct 15, 2024OtherUnknownMW5161107
- SUNSTIM PERIPHERAL NERVE STIMULATOR/SUNSTIM PLUS PERIPHERAL NERVE STIMULATORSep 17, 2024MalfunctionEasymed Instrumentation Co., Ltd.MW5159676
- SUNSTIM PERIPHERAL NERVE STIMULATOR/SUNSTIM PLUS PERIPHERAL NERVE STIMULATORSep 17, 2024MalfunctionEasymed Instrumentation Co., Ltd.MW5159677
- SUNSTIM PERIPHERAL NERVE STIMULATOR/SUNSTIM PLUS PERIPHERAL NERVE STIMULATORSep 17, 2024MalfunctionEasymed Instrumentation Co., Ltd.MW5159678
- CLAVIS EMG/STIM DEVICEOct 19, 2023MalfunctionNatus Manufacturing Limited3005581270-2023-00002
- CLAVIS EMG/STIM DEVICEOct 19, 2023MalfunctionNatus Manufacturing Limited3005581270-2023-00003
- CLAVIS EMG/STIM DEVICEOct 19, 2023MalfunctionNatus Manufacturing Limited3005581270-2023-00004
- CLAVIS EMG/STIM DEVICEOct 19, 2023MalfunctionNatus Manufacturing Limited3005581270-2023-00005
- STIMUPLEXOct 20, 2021Malfunction12664573
Event type breakdown
Recalls
5 recall events for this product code
- B Braun Medical IncOpen, ClassifiedJun 11, 2024
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Z-2131-2024 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedJun 11, 2024
Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Z-2132-2024 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedJun 11, 2024
Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Z-2133-2024 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedJun 11, 2024
Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Z-2134-2024 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedSep 3, 2010
Poly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump, REF 550-100, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block.
Z-2360-2010 · View FDA record ↗
Registered firms
30 firms currently registered for this product code
Xavant Technology (pty) Ltd
Pretoria Gauteng, ZA
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Bowa-electronic Gmbh & Co. Kg
GOMARINGEN Baden-Wurttemberg, DE
Fisher & Paykel Healthcare, Inc.
IRVINE, CA, US
Natus Manufacturing Limited
GORT, Co. Galway, IE
Stockert Gmbh
FREIBURG Baden-Wurttemberg, DE
B. Braun Melsungen Ag
MELSUNGEN Hesse, DE
Pajunk Gmbh Medizintechnologie
GEISINGEN Baden-Wurttemberg, DE
Fisher & Paykel Healthcare, Ltd.
EAST TAMAKI Auckland, NZ
Suzhou Meccan Import And Export Corp.
Suzhou Jiangsu, CN
B. Braun Medical Inc.
Allentown, PA, US
Ha2 Medizintechnik Gmbh
Halberstadt Saxony-Anhalt, DE
Hakko Co., Ltd.
CHIKUMA-SHI Nagano, JP
Salter Labs
El Paso, TX, US
Paul E. Danchell A/s
Jyderup Sjalland, DK
B. Braun Us Device Manufacturing Llc
ALLENTOWN, PA, US
Easymed Instruments Co., Ltd.
Daliang, Shunde, Foshan Guangdong, CN
510(k) clearances
63 clearances for this product code
- Xavant Technology (Pty), Ltd.Oct 16, 2022
K213049 · STIMPOD NMS450 Nerve Stimulator
- PAJUNK GmbH MedizintechnologieJan 6, 2017
K162086 · MultiStim ECO
- Easy Med Instrument Co., Ltd.May 13, 2016
K153045 · SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
- Halyard Health, Inc.Mar 24, 2015
K143095 · MiniStim MS-IVB Peripheral Nerve Stimulator
- Xavant Technology (Pty), Ltd.Nov 6, 2014
K140853 · STIMPOD ST2-3010 NERVE STIMULATOR
- Sunmed, LLCMar 28, 2013
K121743 · EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
- Intronix Technologies Corp.Dec 30, 2011
K111985 · MYOGUIDE SYSTEM MODEL 8008
- Xavant Technology (Pty), Ltd.Feb 17, 2011
K110118 · STIMTRODE SINGLE USE NERVE STIMULATOR