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
3553–3576 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Dec 03, 2001
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY...
K012380 · HAW
Stryker Leibinger
Neurology · 130d
Cleared Nov 28, 2001
MOLDED CRANIAL HELMET
K012920 · MVA
Fairview Orthopedic Laboratory
Neurology · 90d
Cleared Nov 26, 2001
ANEURYSM CLIPS
K013136 · HCH
Gistlstrasse
Neurology · 68d
Cleared Nov 20, 2001
LERMAN & SON CRANIAL ORTHOSIS HELMET
K012830 · MVA
Lerman & Son
Neurology · 89d
Cleared Nov 19, 2001
RECORDING AND STIMULATING ELECTRODE
K012850 · GZL
Radionics, A Division of Tyco...
Neurology · 87d
Cleared Nov 16, 2001
MEDSTAR 100 INTERFERENTIAL STIMLATOR
K013082 · LIH
Mednet Services, Inc.
Neurology · 63d
Cleared Nov 14, 2001
MODIFICATION TO HANDMASTER
K012823 · GZI
Ness-Neuromuscular Electrical...
Neurology · 90d
Cleared Nov 13, 2001
MODEL MES-9000/EMG SYSTEM
K013399 · HCC
Myotronics-Noromed, Inc.
Neurology · 29d
Cleared Nov 08, 2001
SPECTRUM VENTRICULAR CATHETER
K011812 · NHC
Cook, Inc.
Neurology · 150d
Cleared Nov 02, 2001
KADANCE 2000
K012492 · LBB
Kada Research, Inc.
Neurology · 91d
Cleared Oct 31, 2001
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION...
K010202 · GXD
Leslie W. Organ
Neurology · 282d
Cleared Oct 30, 2001
HEMI-ARC SURGICAL NAVIGATOR
K013257 · HAW
Nuvasive, Inc.
Neurology · 29d
Cleared Oct 29, 2001
MICROPLEX COIL SYSTEM
K012145 · HCG
MicroVention, Inc.
Neurology · 111d
Cleared Oct 29, 2001
APEX MEDICAL LCD TENS-VII
K012643 · GZJ
Apex Medical Corp.
Neurology · 77d
Cleared Oct 29, 2001
CRANIAL HELMET
K013458 · MVA
Children'S Hospital
Neurology · 11d
Cleared Oct 25, 2001
WINNER CM4 COMBINATION UNIT
K012848 · GZJ
Rich-Mar Corp.
Neurology · 63d
Cleared Oct 22, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
K012453 · HBC
Sodemsystems
Neurology · 82d
Cleared Oct 22, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
K012457 · HBC
Sodemsystems
Neurology · 82d
Cleared Oct 22, 2001
NAVIGUS II MR
K012719 · HAW
Image-Guided Neurologics, Inc.
Neurology · 69d
Cleared Oct 16, 2001
ALGO 3 NEWBORN HEARING SCREENER
K013137 · GWJ
Natus Medical, Inc.
Neurology · 27d
Cleared Oct 15, 2001
PAM-RL
K010997 · GWQ
Individual Monitoring Systems, Inc.
Neurology · 195d
Cleared Oct 15, 2001
EAR MUFFINS
K012384 · HCC
Bio-Logic Systems Corp.
Neurology · 80d
Cleared Oct 12, 2001
CYCLOTEC AMT CTI TENS DEVICE
K010615 · GZJ
Cyclotec
Neurology · 225d
Cleared Oct 10, 2001
MODIFICATION TO A620 EEG
K012011 · HCC
Stoelting Co.
Neurology · 104d