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
3649–3672 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared May 23, 2001
KM-30 TENS ELECTRODE
K010543 · GXY
Katecho, Inc.
Neurology · 89d
Cleared May 21, 2001
VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT
K003589 · HAW
Brainlab AG
Neurology · 182d
Cleared May 21, 2001
HARMONE-SCHWARZER EEG SYSTEM
K010728 · OLV
Stellate Systems
Neurology · 70d
Cleared May 17, 2001
STEREOTACTIC FRAME BASED SYSTEM
K003486 · HAW
Stryker Instruments
Neurology · 185d
Cleared May 15, 2001
DYNATRON STS
K010565 · LIH
Dynatronics Corp.
Neurology · 78d
Cleared May 15, 2001
DYNATRON STS RX
K010948 · LIH
Dynatronics Corp.
Neurology · 47d
Cleared May 14, 2001
LIFELINES TRACKIT
K010460 · OLV
Lifelines , Ltd.
Neurology · 87d
Cleared May 11, 2001
BIOFIND
K003480 · GZO
Bio-Scan, Inc.
Neurology · 183d
Cleared May 08, 2001
SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION
K010542 · HAW
Surgical Navigation Specialists, Inc.
Neurology · 74d
Cleared May 08, 2001
NEUROFAX, MODELS EEG-1100A, EEG-9100A
K011204 · OLV
Nihon Kohden America, Inc.
Neurology · 19d
Cleared May 07, 2001
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
K010361 · GXR
Medtronic PS Medical
Neurology · 90d
Cleared May 03, 2001
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230...
K002565 · GXD
Baylis Medical Co., Inc.
Neurology · 259d
Cleared May 03, 2001
NEUROPLUS, MODEL A10040, A10041, A10042, A10043
K010638 · GXY
Vermont Medical, Inc.
Neurology · 59d
Cleared May 02, 2001
MACROPORENS CRANILOC
K002334 · GXR
Macropore Biosurgery, Inc.
Neurology · 274d
Cleared Apr 27, 2001
TRANSAMERICAN TENS
K010782 · GZJ
Transamerica Medical Systems
Neurology · 43d
Cleared Apr 25, 2001
CRANIAL MOLDING ORTHOSIS
K010273 · MVA
Orthotic Solutions, Inc.
Neurology · 86d
Cleared Apr 20, 2001
MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042,...
K010341 · GWG
Medtronic PS Medical
Neurology · 74d
Cleared Apr 20, 2001
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
K010969 · GXD
Stryker Instruments
Neurology · 18d
Cleared Apr 09, 2001
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
K010086 · GWQ
Excel Tech. , Ltd.
Neurology · 88d
Cleared Apr 02, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
K010092 · GWF
Excel Tech. , Ltd.
Neurology · 81d
Cleared Mar 26, 2001
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
K010088 · GWQ
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
K010089 · GWQ
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
K010090 · GWF
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 19, 2001
STERILE SUBDERMAL NEEDLE ELECTRODES
K010019 · GXZ
Nicolet Biomedical, Inc.
Neurology · 76d