Electromyograph, Diagnostic
Physical Medicine · 21 CFR 890.1375
Recent MDR events
111 adverse event reports on file
- NVM5Apr 16, 2026InjuryNuvasive, Inc.2031966-2026-00053
- NIM® 2.0 INTERFACENov 25, 2025MalfunctionMedtronic Xomed Inc.1045254-2025-02627
- NIM® 2.0 INTERFACENov 25, 2025MalfunctionMedtronic Xomed Inc.1045254-2025-02629
- PATIENT INTERFACE NIM4CPB1 NIM 4.0Nov 10, 2025MalfunctionMedtronic Xomed Inc.1045254-2025-02463
- NIM® 2.0 INTERFACEJun 28, 2024MalfunctionMedtronic Xomed Inc.1045254-2024-00968
- SIERRA SUMMITDec 2, 2022MalfunctionCadwell Industries, Inc.15904337
- VIKING EDX INTERNATIONALAug 30, 2022MalfunctionNatus Neurology Incoporated3010611950-2022-00003
- ELECTRODIAGNOSTIC FUNCTIONAL ASSESSMENT (EFA) EFA-STMOct 5, 2021InjuryEmerge Diagnostics, Inc.MW5104411
- NIM® 2.0 MAINFRAMEMay 25, 2021InjuryMedtronic Xomed Inc.1045254-2021-00258
- NIM® 2.0 MAINFRAME - PULSEFeb 12, 2020MalfunctionMedtronic Xomed Inc.1045254-2020-00082
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
173 firms currently registered for this product code
Fideltronik Poland Sp. Z O.o.
Sucha Beskidzka Malopolskie, PL
Covidien
- Santo Domingo, DO
Nuvasive, Inc.
SAN DIEGO, CA, US
Nexstim Plc
Helsinki Uusimaa, FI
Arch Medical Solutions - Memphis
Lexington, TN, US
Isomedix Operations Inc
GROVEPORT, OH, US
Hipp Medical Ag
Renquishausen Baden-Wurttemberg, DE
Inomed Medizintechnik Gmbh
EMMENDINGEN Baden-Wurttemberg, DE
Globus Medical, Inc.
Memphis, TN, US
Ferry Machine Corporation
Oakland, NJ, US
Cadwell Industries, Inc.
KENNEWICK, WA, US
Alphatec Spine, Inc.
Carlsbad, CA, US
Natus Neurology Incorporated
Middleton, WI, US
Arch Medical Solutions - Olive Branch
Olive Branch, MS, US
Arch Medical Solutions - Memphis
BARTLETT, TN, US
Isomedix Operations Inc.
SPARTANBURG, SC, US
Shandong Weigao Orthopaedic Device Co.,ltd
weihai Shandong, CN
Atl Technology Cr Limitada
Alajuela, CR
Hcltech
Pittston, PA, US
510(k) clearances
75 clearances for this product code
- Natus Neurology IncorporatedDec 19, 2017
K172743 · Natus VikingQuest
- Dorsavi, Ltd.Jul 14, 2017
K163150 · ViMove2
- Cadwell Industries, Inc.Mar 1, 2017
K162383 · Cadwell Sierra Summit, Cadwell Sierra Ascent
- Dorsavi, Ltd.May 28, 2015
K142494 · ViMove
- Dorsa VI Pty., Ltd.Jul 11, 2014
K131094 · VIMOVE
- Oktx, LLCSep 13, 2013
K123902 · PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
- Precision Biometrics, Inc.Aug 1, 2013
K123399 · MYOVISION 3.0 WIREFREE SYSTEM
- Medical Technologies, Inc.Feb 2, 2012
K113074 · CMAP PRO