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
2497–2520 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jun 30, 2009
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
K091641 · HCG
MicroVention, Inc.
Neurology · 26d
Cleared Jun 26, 2009
GUARDIAN 150 ELECTRODE
K083756 · GXY
Selectivemed Components, Inc.
Neurology · 191d
Cleared Jun 25, 2009
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
K091317 · GZJ
Bio-Medical Research, Ltd.
Neurology · 52d
Cleared Jun 23, 2009
JIAJIAN SELF-ADHESIVE ELECTRODE
K090198 · GXY
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 147d
Cleared Jun 23, 2009
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
K091055 · IKT
Rhythmlink International, LLC
Neurology · 71d
Cleared Jun 23, 2009
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
K091056 · IKT
Rhythmlink International, LLC
Neurology · 71d
Cleared Jun 22, 2009
MICROPLEX COIL SYSTEM-COSMOS
K090891 · HCG
MicroVention, Inc.
Neurology · 84d
Cleared Jun 08, 2009
NUVASIVE NEURO VISION SYSTEM
K090298 · GWF
Nuvasive, Inc.
Neurology · 122d
Cleared Jun 05, 2009
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
K090922 · GZJ
Empi
Neurology · 65d
Cleared Jun 05, 2009
RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK...
K090951 · GXY
Rs Medical
Neurology · 63d
Cleared Jun 02, 2009
PENTA LEAD KITS, MODELS: 3227-3234
K090907 · GZB
Advanced Neuromodulation Systems
Neurology · 62d
Cleared Jun 02, 2009
CODMAN HAKIM MICRO II VALVE
K091346 · JXG
Codman & Shurtleff, Inc.
Neurology · 26d
Cleared May 29, 2009
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
K090052 · QJQ
Johari Digital Healthcare , Ltd.
Neurology · 142d
Cleared May 28, 2009
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
K090957 · GWL
I2s Micro Implantable Systems, LLC
Neurology · 52d
Cleared May 27, 2009
NEUROMETRIX BIOAMPLIFIER
K083322 · GWL
Neurometrix, Inc.
Neurology · 196d
Cleared May 22, 2009
FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION
K083441 · GXY
Motion Medical Products, LLC
Neurology · 183d
Cleared May 15, 2009
NEUCODIA
K081591 · GWE
Verisci Corporation
Neurology · 343d
Cleared May 08, 2009
CRANIAL IMAGE GUIDED SURGERY SYSTEM
K082060 · HAW
Brainlab AG
Neurology · 291d
Cleared May 08, 2009
PMT SUBDURAL CORTICAL ELECTRODES
K082474 · GYC
Pmt Corp.
Neurology · 253d
Cleared May 08, 2009
FLEX-TENS
K090717 · GZJ
Emsi
Neurology · 51d
Cleared May 06, 2009
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
K081640 · HCH
Gimmi GmbH
Neurology · 329d
Cleared May 06, 2009
LASER TOUCHONE
K083822 · GZJ
Laser Health Technologies, LLC
Neurology · 135d
Cleared May 06, 2009
PAINMASTER MCT PATCH
K090042 · NUH
Newmark, Inc.
Neurology · 120d
Cleared May 01, 2009
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
K080355 · HAW
Elekta Instrument AB
Neurology · 445d