FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,291 results
3769–3792 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Aug 04, 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226 · JXG
Radionics, Inc.
Neurology · 399d
Cleared Aug 03, 2000
NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
K002053 · HAW
Orthosoft, Inc.
Neurology · 28d
Cleared Aug 02, 2000
POLYMEDIC UPA NERVE STIMULATION NEEDLE
K990100 · GXZ
Te ME NA S.A.R.L.
Neurology · 576d
Cleared Aug 01, 2000
DA VINCHI EMG/EP ISA1004EP
K001467 · GWE
Airsep Corp.
Neurology · 83d
Cleared Jul 26, 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · HAW
Radionics, Inc.
Neurology · 29d
Cleared Jul 19, 2000
KSEA BIPOLAR COAGULATING ELECTRODES
K001630 · GWG
Karl Storz Endoscopy
Neurology · 54d
Cleared Jul 11, 2000
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256...
K001324 · OLT
Neuro Scan Labs
Neurology · 76d
Cleared Jul 07, 2000
OPI BAND
K001167 · MVA
Orthomerica Products, Inc.
Neurology · 88d
Cleared Jul 06, 2000
MEDISANA DIGITAL TENS
K994265 · GZJ
Fuji Dynamics Limited
Neurology · 202d
Cleared Jul 06, 2000
FDTENS 2010
K994266 · GZJ
Fuji Dynamics Limited
Neurology · 202d
Cleared Jul 05, 2000
CRYSTAL-EEG MODEL 15
K001110 · OMC
Cleveland Medical Devices, Inc.
Neurology · 90d
Cleared Jul 05, 2000
COMFORT STIM
K001117 · GXY
R & D Medical Products, Inc.
Neurology · 90d
Cleared Jun 30, 2000
MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
K001069 · OLW
Physiometrix, Inc.
Neurology · 88d
Cleared Jun 30, 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
K001101 · GWF
Excel Tech. , Ltd.
Neurology · 86d
Cleared Jun 30, 2000
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
K001103 · GWQ
Excel Tech. , Ltd.
Neurology · 86d
Cleared Jun 30, 2000
STEATHSTATION TREATMENT GUIDANCE PLATFORM
K001801 · HAW
Medtronic Surgical Navigation
Neurology · 16d
Cleared Jun 29, 2000
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL,...
K001705 · GYB
Chester Labs, Inc.
Neurology · 24d
Cleared Jun 27, 2000
MODIFICATION TO NC-STAT
K000565 · JXE
Neurometrix, Inc.
Neurology · 126d
Cleared Jun 16, 2000
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND...
K000892 · OLT
Datex-Ohmeda, Inc.
Neurology · 88d
Cleared Jun 16, 2000
ULTRASTIM ELECTRODE, MODEL US4040
K000947 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 85d
Cleared Jun 12, 2000
STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
K001284 · HAW
Medtronic Surgical Navigation...
Neurology · 52d
Cleared Jun 07, 2000
SELF ADHERING NAVIGUS GUIDE
K001192 · HAW
Image-Guided Neurologics, Inc.
Neurology · 56d
Cleared Jun 07, 2000
ENDOR 2000
K984376 · GZJ
T.C. Medical, Inc.
Neurology · 548d
Cleared May 17, 2000
INTERCURE LTD. RESPI-LOW
K000405 · HCC
Intercure , Ltd.
Neurology · 100d