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
1993–2016 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Nov 14, 2014
WEARABLE THERAPY GARMENTS
K141342 · GXY
Axiobionics, LLC
Neurology · 177d
Cleared Nov 14, 2014
NUVASIVE NVM5 SYSTEM
K141968 · PDQ
Nuvasive, Inc.
Neurology · 116d
Cleared Nov 14, 2014
MINOP Disposable Introducer 26F
K142315 · GWG
Aesculap, Inc.
Neurology · 87d
Cleared Nov 13, 2014
Barricade Embolization Coil System
K142513 · HCG
Blockade Medical
Neurology · 66d
Cleared Nov 12, 2014
HEALTH EXPERT ELCTRONIC STIMULATOR
K133929 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 324d
Cleared Nov 07, 2014
PANTHEON ELECTROSTIMULATOR
K133980 · BWK
Pantheon Research
Neurology · 315d
Cleared Nov 07, 2014
INNOVASIS CRANIAL SYSTEM
K141644 · GWO
Innovasis, Inc.
Neurology · 141d
Not Cleared Nov 07, 2014
ZAP-IT!
DEN100024 · OSG
Ecobrands , Ltd.
Neurology · 1520d
Not Cleared Nov 07, 2014
ZANZA-CLICK
DEN130019 · OSG
Tecnimed S.R.L.
Neurology · 617d
Cleared Nov 05, 2014
E-Shield Multi-paried Subdermal Needle Electrodes
K142470 · GXZ
Neuroinvent, Inc.
Neurology · 63d
Cleared Oct 22, 2014
SOLITAIRE 2 REVASCULARIZATION DEVICE
K141491 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 139d
Cleared Oct 15, 2014
DANA
K141865 · LQD
Anthrotronix, Inc.
Neurology · 97d
Cleared Oct 10, 2014
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
K141399 · GZB
Stimwave Technologies Incorporated
Neurology · 135d
Cleared Oct 10, 2014
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
K141869 · GWM
Hemedex Incorporated
Neurology · 91d
Cleared Oct 06, 2014
STARBAND, STARLIGHT
K141842 · MVA
Orthomerica Products, Inc.
Neurology · 90d
Cleared Oct 03, 2014
CRANIOPLUG
K140309 · GXR
Ossdsign AB
Neurology · 238d
Cleared Oct 03, 2014
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
K141139 · NCX
Zoll Circulation
Neurology · 154d
Cleared Oct 02, 2014
Electro Auricular Device
K140530 · BWK
Navigant Consulting, Inc.
Neurology · 212d
Cleared Sep 26, 2014
MEDLINE NEURO SPONGE
K140369 · HBA
Medline Industries, Inc.
Neurology · 224d
Cleared Sep 25, 2014
PHANTOM XL INSULATED DILATORS
K140088 · PDQ
Tedan Surgical Innovations, LLC
Neurology · 254d
Cleared Sep 17, 2014
ELECTRONIC PULSE STIMULATOR
K141260 · NUH
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 125d
Cleared Sep 04, 2014
HFD100 ROCKER ARM ACCESSORY
K141950 · HBL
Imris, Inc.
Neurology · 48d
Cleared Aug 28, 2014
EASYSTIM TN28_OTC
K140168 · NUH
Easymed Instruments Co., Ltd.
Neurology · 217d
Cleared Aug 26, 2014
TENS
K133979 · NUH
Sunmas (H.K.) Trading Limited
Neurology · 243d