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
3913–3936 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jul 06, 1999
DURAGEN DURAL GRAFT MATRIX
K982180 · GXQ
Integra Lifesciences Corp.
Neurology · 379d
Cleared Jun 25, 1999
FRAMELESS NEUROMATE
K991081 · HAW
Integrated Surgical Systems, Inc.
Neurology · 86d
Cleared Jun 24, 1999
SIEMENS INFINITY EEG POD
K991012 · OLT
Siemens Medical Solutions USA, Inc.
Neurology · 90d
Cleared Jun 24, 1999
RENEW LEAD EXTENSION
K991784 · GZB
Advanced Neuromodulation Systems
Neurology · 30d
Cleared Jun 23, 1999
Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
K984298 · HAW
Z-Kat, Inc.
Neurology · 203d
Cleared Jun 23, 1999
ACTIWATCH-SCORE
K991033 · GWQ
Mini-Mitter Co., Inc.
Neurology · 86d
Cleared Jun 22, 1999
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550,...
K982950 · IKT
Chalgren Enterprises, Inc.
Neurology · 305d
Cleared Jun 22, 1999
BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150
K991199 · GXY
Biomed Products
Neurology · 75d
Cleared Jun 18, 1999
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM...
K982096 · GXY
Rapid Mfg. Co.
Neurology · 368d
Cleared Jun 09, 1999
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
K991077 · GZL
Microrecording Systems Consultants, LLC
Neurology · 70d
Cleared Jun 07, 1999
MEDIPOINT
K982961 · GZJ
Medipoint , Ltd.
Neurology · 287d
Cleared Jun 04, 1999
SUGITA TITANIUM ANEURYSM CLIP
K990202 · HCH
Mizuho America, Inc.
Neurology · 134d
Cleared Jun 03, 1999
XK-95 HIGH SPEED MOTOR DRILL SYSTEM
K984035 · HBE
Komet Medical
Neurology · 203d
Cleared Jun 03, 1999
LAMITRODE LEADS
K990469 · GZB
Advanced Neuromodulation Systems
Neurology · 107d
Cleared Jun 03, 1999
INSIGHT MILLENNIUM
K990778 · HCC
Fasstech
Neurology · 86d
Cleared Jun 03, 1999
KSEA NEURO-FIBERSCOPE
K991069 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 64d
Cleared May 27, 1999
ELECTRODE NEEDLES
K990015 · IKT
Technomed Europe
Neurology · 143d
Cleared May 26, 1999
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER...
K981246 · JXG
Integra Neurocare, LLC
Neurology · 415d
Cleared May 19, 1999
VECTORVISION2
K983831 · HAW
Brainlab AG
Neurology · 201d
Cleared May 19, 1999
WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE...
K990522 · OLV
Lamont Medical, Inc.
Neurology · 90d
Cleared May 19, 1999
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
K990538 · HCC
Brainmaster
Neurology · 89d
Cleared May 19, 1999
DIAMOND II VALVE
K991429 · JXG
Phoenix Biomedical Corp.
Neurology · 23d
Cleared May 17, 1999
SYNERGY IOM SYSTEM
K984052 · IKN
Oxford Instruments Medical Systems
Neurology · 185d
Cleared Apr 29, 1999
THE BAGNOLI-8 EMG SYSTEM
K990356 · HCC
Delsys, Inc.
Neurology · 83d