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
1849–1872 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Aug 14, 2015
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043 · NUH
Andon Health Co, Ltd.
Neurology · 217d
Cleared Aug 13, 2015
Mitsar-EEG
K143233 · GWQ
Mitsar Co., Ltd.
Neurology · 276d
Cleared Aug 12, 2015
PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE
K151929 · OMB
Persyst Development Corporation
Neurology · 29d
Cleared Aug 06, 2015
Penumbra System 110 Aspiration Tubing
K151623 · NRY
Penumbra, Inc.
Neurology · 51d
Cleared Jul 31, 2015
MagVita TMS Therapy System
K150641 · OBP
Tonica Elektronik A/S
Neurology · 142d
Cleared Jul 30, 2015
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and...
K150371 · GXI
Diros Technology, Inc.
Neurology · 167d
Cleared Jul 28, 2015
Philips Self-Adhesive Electrodes
K151033 · GXY
Philips Consumer Lifestyle
Neurology · 102d
Cleared Jul 28, 2015
Axium Detachable Coil System
K151447 · HCG
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 60d
Cleared Jul 27, 2015
QuadraSphere Microspheres
K151187 · KRD
Biosphere Medical, S.A.
Neurology · 84d
Cleared Jul 27, 2015
Barricade Embolization Coil System
K151760 · HCG
Blockade Medical
Neurology · 28d
Cleared Jul 21, 2015
TENS AND POWERED MUSCLE STIMULATOR
K143268 · NUH
Shenzhen As-Tec Technology Co., Ltd.
Neurology · 250d
Cleared Jul 21, 2015
PulseRelief
K151035 · NUH
Philips Consumer Lifestyle
Neurology · 95d
Cleared Jul 10, 2015
Penumbra Smart Coil
K151572 · HCG
Penumbra, Inc.
Neurology · 29d
Cleared Jul 08, 2015
NavSuite3 Kit
K150301 · HAW
Stryker Leibinger GmbH & Co. KG -...
Neurology · 152d
Cleared Jul 08, 2015
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
K151536 · HBG
Mri Interventions, Inc.
Neurology · 30d
Cleared Jul 06, 2015
Electronic Pulse Stimulator
K150995 · NUH
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 82d
Cleared Jul 01, 2015
STARband, STARlight
K151147 · OAN
Orthomerica Products, Inc.
Neurology · 62d
Cleared Jun 29, 2015
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and...
K150518 · JXL
Dupaco, Inc.
Neurology · 119d
Cleared Jun 24, 2015
Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver...
K151387 · HBW
Stryker
Neurology · 29d
Cleared Jun 23, 2015
DiscoverEEG System, Model DE-401
K142834 · OLT
Neurowave Systems, Inc.
Neurology · 266d
Cleared Jun 19, 2015
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
K133995 · OLT
Neurosoft , Ltd.
Neurology · 540d
Cleared Jun 12, 2015
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH...
K150319 · HCG
Codman & Shurtleff, Inc.
Neurology · 123d
Cleared Jun 12, 2015
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
K150378 · GZT
Nico Corporation
Neurology · 119d
Cleared Jun 12, 2015
Trevo XP ProVue Retriever (4x30mm)
K150616 · NRY
Concentric Medical, Inc.
Neurology · 94d