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
1993–2016 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jul 02, 2014
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
K141452 · GWO
Jeil Medical Corporation
Neurology · 30d
Cleared Jun 27, 2014
HICUT HIGHSPEED INSTRUMENT
K130755 · HBE
Adeor Medical AG
Neurology · 465d
Cleared Jun 27, 2014
HIVOX ELECTRIC STIMULATOR OTC TENS
K140650 · NUH
Hivox Biotek, Inc.
Neurology · 106d
Cleared Jun 27, 2014
P-STIM
K140788 · BWK
Biegler GmbH
Neurology · 88d
Not Cleared Jun 26, 2014
REWALK
DEN130034 · PHL
Argo Medical Technologies, Inc.
Neurology · 374d
Cleared Jun 13, 2014
MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
K140462 · GWO
Synthes USA Products, LLC
Neurology · 109d
Cleared Jun 06, 2014
STARBAND AND STARLIGHT
K140353 · MVA
Orthomerica Products, Inc.
Neurology · 114d
Cleared Jun 05, 2014
STRYKER KWIC NEEDLE
K140868 · HAW
Orthovita, Inc.
Neurology · 63d
Cleared Jun 03, 2014
AXON-BUS PROSTHETIC SYSTEM
K123795 · GXY
Otto Bock Austria
Neurology · 540d
Cleared May 30, 2014
CP RELIEF WAND
K133779 · GZJ
Mid-America Medical Innovations, LLC
Neurology · 169d
Cleared May 29, 2014
SENTIO MMG
K131304 · PDQ
Innovative Surgical Solutions, LLC...
Neurology · 387d
Cleared May 28, 2014
REHASTIM 2, ERIGOPRO (FES)
K132416 · GZI
Hasomed GmbH
Neurology · 299d
Cleared May 23, 2014
Best-AV2 Pro-Sport(tm)
K123099 · GZJ
Avazzia, Inc.
Neurology · 598d
Cleared May 21, 2014
SPRINGTMS TOTAL MIGRAINE SYSTEM
K140094 · OKP
Eneura Therapeutics, LLC
Neurology · 127d
Cleared May 21, 2014
SKINTACT
K140340 · GXY
Leonhard Lang GmbH
Neurology · 99d
Cleared May 20, 2014
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
K133082 · GXN
Osteosymbionics, LLC
Neurology · 232d
Cleared May 19, 2014
PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE
K133793 · OMB
Persyst Development Corporation
Neurology · 157d
Cleared May 16, 2014
NUVASIVE NVM5 SYSTEM
K132694 · PDQ
Nu Vasive, Incorporated
Neurology · 260d
Cleared May 13, 2014
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
K133317 · NRY
Penumbra, Inc.
Neurology · 197d
Cleared May 02, 2014
NUVASIVE EMG ENDOTRACHEAL TUBE
K133530 · PDQ
Nu Vasive, Incorporated
Neurology · 168d
Cleared May 02, 2014
SWIFT-LOCK ANCHOR
K140272 · GZB
St Jude Medical
Neurology · 88d
Cleared Apr 30, 2014
BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
K130065 · NFO
Biosonic Technologies, LLC
Neurology · 475d
Cleared Apr 29, 2014
NEUROMATE FRAMELESS GEN II
K132755 · HAW
Renishaw Mayfield Sarl
Neurology · 238d
Cleared Apr 24, 2014
NEURAGEN 3D
K130557 · JXI
Integra LifeSciences Corporation
Neurology · 416d