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
2545–2568 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jan 29, 2009
MAICO MB 11 WITH BERAPHONE PROBE
K082035 · GWJ
Maico-Diagnostics
Neurology · 196d
Cleared Jan 27, 2009
CAMLAB CRANIAL ORTHOSIS HELMET
K081787 · OAN
Biosculptor Corporation
Neurology · 217d
Cleared Jan 23, 2009
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
K081279 · GXY
Transfer Technology
Neurology · 262d
Cleared Jan 21, 2009
UNIVERSAL ELECTRODES
K083818 · GXY
Neurometrix, Inc.
Neurology · 30d
Cleared Jan 08, 2009
PAIN VISION, MODEL PS-2100
K072882 · LLN
Osachi Co., Ltd.
Neurology · 457d
Cleared Jan 06, 2009
ULTIMA FIVE
K083494 · GZJ
Pain Management Technologies
Neurology · 42d
Cleared Jan 02, 2009
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
K083646 · HCG
Micrus Endovascular Corporation
Neurology · 24d
Cleared Dec 30, 2008
NICOLET CORTICAL STIMULATOR
K072964 · GYC
Cardinal Health, Inc.
Neurology · 438d
Cleared Dec 29, 2008
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
K082010 · HBF
Stryker Ireland Ltd., Instruments...
Neurology · 167d
Cleared Dec 24, 2008
TWIN NEUROTRAC-III
K081551 · OMA
Astro-Med, Inc.
Neurology · 204d
Cleared Dec 22, 2008
CRANIAL PERFORATOR
K082637 · HBF
The Anspach Effort, Inc.
Neurology · 103d
Cleared Dec 16, 2008
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
K083063 · OLW
Mennen Medical , Ltd.
Neurology · 63d
Cleared Dec 16, 2008
NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
K083538 · OBP
Neuronetics
Neurology · 18d
Cleared Dec 15, 2008
COMBOCARE 2000
K083202 · GZJ
Xanacare Technologies, LLC
Neurology · 46d
Cleared Dec 09, 2008
RUGALIFT, MODEL# V.2.1
K071573 · NFO
Fatrotek S.R.L.
Neurology · 550d
Cleared Dec 08, 2008
MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
K080499 · GWF
The Magstim Company , Ltd.
Neurology · 287d
Cleared Dec 05, 2008
STARBAND
K082950 · OAN
Orthomerica Products, Inc.
Neurology · 63d
Cleared Nov 28, 2008
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
K082011 · GZJ
Bio-Medical Research, Ltd.
Neurology · 136d
Cleared Nov 28, 2008
GE ENTROPY SENSOR
K082540 · GXY
Ge Healthcare
Neurology · 87d
Cleared Nov 25, 2008
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
K081867 · HAW
Mako Surgical Corp.
Neurology · 147d
Cleared Nov 24, 2008
MODEL ES-130
K081943 · BWK
Ito Co., Ltd.
Neurology · 139d
Cleared Nov 20, 2008
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY,...
K083076 · JXG
Medtronic Neurosurgery
Neurology · 35d
Cleared Nov 10, 2008
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
K080771 · GXI
Top Corp.
Neurology · 236d
Cleared Nov 06, 2008
OSV II
K081773 · JXG
Integra Neurosciences Implants S.A.
Neurology · 136d