GWF
CAREFUSION NICOLET EDX
- Advisory panel
- Neurology
- Total cleared
- 139
Adverse events under product code GWF
product code GWF- Malfunction
- 2,364
- Other
- 4
- Total
- 2,368
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GWF
1–100 of 139- K252842 — SafeOp 3: Neural Informatix System
- K243982 — Nicolet EDX
- K243495 — Natus Ultrapro S100 (982A0594)
- K242345 — Delphi Stimulator
- K234092 — SafeOp 3: Neural Informatix Systeem
- K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
- K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
- K230415 — Cadwell Guardian
- K213849 — SafeOp 2: Neural Informatix System
- K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
- K192823 — MEGA-TMS
- K190703 — Neuro-IOM system with Neuro-IOM.NET software
- K200759 — NIM Vital, Nerve Integrity Monitor
- K182542 — The EPAD 2 System
- K170677 — Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
- K162873 — MEP Monitor
- K162199 — Cascade IOMAX Intraoperative Monitor
- K160280 — MagPro R20
- K150220 — STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
- K142624 — Neuromaster G1 MEE200
- K132616 — EPAD
- K130403 — MAGSTIM DOUBLE 70-2 COIL
- K123843 — NEUROEPG SYSTEM
- K130346 — SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION
- K120397 — MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
- K112881 — NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
- K120979 — CAREFUSION NICOLET EDX
- K112052 — CAREFUSION NICOLET EDX
- K111647 — C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
- K110140 — NEUROVISION NERVE LOCATOR MONITOR
- K093304 — PROTEKTOR 32
- K094054 — MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
- K091940 — MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
- K083371 — NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
- K091457 — NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
- K090298 — NUVASIVE NEURO VISION SYSTEM
- K082614 — EVOX ELECTRO DIAGNOSTIC DEVICE
- K083124 — NIM 3.0
- K080499 — MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
- K071969 — SEN-4100 ELECTRIC STIMULATOR
- K072343 — NEUROVISION JJB SYSTEM
- K071821 — COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
- K062765 — MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
- K061639 — ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON
- K061645 — MAGPRO, MODEL R30
- K060847 — MAGSTIM 200-2
- K061113 — ORTHOMON
- K051864 — MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
- K051357 — DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH
- K051178 — MEE-1000A NEUROMASTER
- K050798 — ECLIPSE NEUROLOGICAL WORKSTATION
- K051384 — MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
- K030526 — PEDIGUARD NERVE DETECTOR SYSTEM
- K042350 — TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
- K040358 — XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
- K031930 — HIGH SPEED EMG MODULE
- K032741 — EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION
- K020400 — DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
- K010092 — XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
- K010090 — XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
- K010087 — XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
- K002969 — XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
- K002773 — NEUROMAP WITH NEURO 100
- K000963 — DA VINCHI EEG AND EMG/EP SYSTEMS
- K001101 — XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
- K992911 — MAGSTIM RAPID
- K991899 — NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
- K992313 — XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
- K981405 — SYNERGY LT
- K980866 — MEDI-DX 7000 CPT WITH AMREX ELECTRODES
- K971740 — AMPLAID MK12
- K972959 — AMPLAID MK22
- K971819 — EPOCH 2000 NEUROLOGICAL WORKSTATION
- K965065 — TECA. MILLENNIUM
- K963662 — GALILEO EVOKED POTENTIALRE
- K962455 — FOUR-CHANNEL PREAMPLIFIER
- K962457 — TWO-CHANNEL PREAMPLIFIER
- K962458 — CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
- K932994 — EVOKED POTENTIAL SYSTEM-1.0
- K960170 — ELECTROENCEPHALOGRAPH (EEG)
- K955257 — SS102 DUAL CHANNEL SEP STIMULATOR
- K952294 — NEURONET
- K944547 — DANTEC KEYPOINT
- K950208 — NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
- K931923 — DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)
- K926516 — DANTEC MAGNETIC STIMULATOR MAGPRO
- K931428 — CADWELL 6200 A
- K924723 — CADWELL SIERRA
- K924127 — DANTEC EVOLUTION
- K923303 — SAPPHIRE PREMIERE
- K923315 — NICOLET ARK SYSTEM
- K912685 — MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
- K915652 — NICOLET PORATBLE SPIRIT SYSTEM
- K912775 — SAPPHIRE 4ME EMG/EP SYSTEM
- K905059 — HIGH SPEED MAGNETIC STIMULATOR
- K902607 — DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)
- K903731 — SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
- K894560 — QSI 9000
- K900482 — SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG
- K896567 — CANTATA EMG/EVOKED RESPONSE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.