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
1969–1992 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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
Cleared Aug 22, 2014
PERSONAL KINETIGRAPH (PKG) SYSTEM
K140086 · GYD
Gkc Manufacturing Pty, Ltd.
Neurology · 220d
Cleared Aug 22, 2014
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III...
K141446 · GWJ
Natus Medical Incorporated
Neurology · 81d
Not Cleared Aug 22, 2014
Medtronic DUET External Drainage and Monitoring System
DEN120017 · PCB
Medtronic Neurosurgery
Neurology · 609d
Cleared Aug 08, 2014
WALKAIDE SYSTEM
K140886 · GZI
Innovative Neurotronics, Inc.
Neurology · 123d
Cleared Aug 06, 2014
IQ TECHNOLOGIES
K131290 · NUH
Iq Technologies, Inc.
Neurology · 457d
Cleared Jul 31, 2014
TRAXCESS 14 GUIDEWIRE
K133725 · MOF
MicroVention, Inc.
Neurology · 237d
Cleared Jul 25, 2014
BNA ANALYSIS SYSTEM
K121119 · OLU
Eiminda , Ltd.
Neurology · 834d
Cleared Jul 25, 2014
HIVOX SELF ADHESIVE ELECTRODE GEL PADS
K131720 · GXY
Hivox Biotek, Inc.
Neurology · 408d
Cleared Jul 25, 2014
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K133444 · HAW
Medtronic Navigation, Inc.
Neurology · 255d
Cleared Jul 23, 2014
CADWELL SPIKE AND SEIZURE DETECTOR
K140552 · OMB
Cadwell
Neurology · 141d
Cleared Jul 23, 2014
DYNAMIC NEUROSCREENING DEVICE
K141208 · LQW
Prosenex
Neurology · 75d
Cleared Jul 21, 2014
BABYMEG BIOMAGNETOMETER SYSTEM
K133419 · OLY
Tristan Technologies, Inc.
Neurology · 256d
Cleared Jul 18, 2014
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
K140200 · GXZ
Neuroinvent, Inc.
Neurology · 172d
Cleared Jul 11, 2014
VIMOVE
K131094 · IKN
Dorsa VI Pty., Ltd.
Neurology · 449d
Cleared Jul 11, 2014
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
K131513 · GZJ
Ritm Okb Zao
Neurology · 409d
Cleared Jul 11, 2014
NEUROPACE BURR HOLE COVER
K141368 · GXR
NeuroPace, Inc.
Neurology · 49d
Cleared Jul 03, 2014
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
K131923 · GZI
Techlink International
Neurology · 372d
Cleared Jul 03, 2014
ASCEND
K140333 · NUH
Neurometrix, Inc.
Neurology · 143d
Cleared Jul 03, 2014
POD SYSTEM
K141134 · HCG
Penumbra, Inc.
Neurology · 63d