Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Neurology ×
6,334 results
1945–1968 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Apr 02, 2015
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
K141687 · JXG
Aesculap, Inc.
Neurology · 294d
Cleared Apr 02, 2015
MYGAIT STIMULATION SYSTEM
K141812 · GZI
Otto Bock Healthcare Products GmbH
Neurology · 269d
Cleared Apr 02, 2015
BRIGHTMATTER NAVIGATION SYSTEM
K142024 · HAW
Synaptive Medical, Inc.
Neurology · 251d
Cleared Mar 27, 2015
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
K141385 · HBW
Depuy Synthes Companies of Johnson &...
Neurology · 304d
Cleared Mar 27, 2015
NuVasive NVM5 System
K143641 · PDQ
Nu Vasive, Incorporated
Neurology · 95d
Cleared Mar 25, 2015
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER,...
K141833 · HAW
Medtronic Navigation, Inc.
Neurology · 261d
Cleared Mar 23, 2015
BioniCare Hand System
K142236 · NYN
Vision Quest Industries, Inc.
Neurology · 222d
Cleared Mar 20, 2015
DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System
K142344 · HAW
Izi Medical Products, LLC
Neurology · 210d
Cleared Mar 18, 2015
Penumbra Smart Coil
K143218 · HCG
Penumbra, Inc.
Neurology · 128d
Cleared Mar 16, 2015
EASYDRILL AUTOSTOP CRANIAL PERFORATOR
K141455 · HBF
Micromar Ind. Com. , Ltd.
Neurology · 287d
Cleared Mar 16, 2015
Sleepware G3
K142988 · OLZ
Respironics, Inc.
Neurology · 151d
Cleared Mar 05, 2015
Nerve Monitoring Cable System
K142438 · PDQ
Pioneer Surgical Technology, Inc....
Neurology · 188d
Cleared Mar 04, 2015
NIHON KOHDEN AE-918P NEURO UNIT
K130238 · OMA
Nihon Kohden Corp.
Neurology · 762d
Cleared Mar 04, 2015
DOLPHIN NEUROSTIM OTC
K133789 · NUH
Acumed Medical , Ltd.
Neurology · 447d
Cleared Feb 27, 2015
ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
K141123 · GWO
Alliance Partners, LLC
Neurology · 302d
Cleared Feb 27, 2015
V-GUIDE FOR VENTRICULOSTOMIES
K141559 · HAW
Arc Surgical, LLC
Neurology · 260d
Cleared Feb 20, 2015
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician...
K142432 · GZF
Bioness, Inc.
Neurology · 175d
Cleared Feb 19, 2015
Codman Certas Plus Programmable Valve
K143111 · JXG
Medos International SARL
Neurology · 113d
Cleared Feb 18, 2015
Polysmith Sleep System
K142774 · OLV
Neurotronics, Inc.
Neurology · 145d
Cleared Feb 13, 2015
COGNISION EEG/EP SYSTEM
K141316 · OLT
Neuronetrix Solutions
Neurology · 269d
Cleared Feb 13, 2015
GALILEO NT
K142064 · OLT
Eb Neuro S.P.A.
Neurology · 198d
Cleared Feb 10, 2015
OPTIMUS NEURO SYSTEM
K141911 · GWO
Osteonic Co., Ltd.
Neurology · 210d
Cleared Feb 05, 2015
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
K141516 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 241d
Cleared Feb 03, 2015
BWMINI EEG, BWMINIHST, BWMINI PSG
K131335 · GWQ
Neurovirtual USA, Inc.
Neurology · 635d