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
3289–3312 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Aug 01, 2003
GUGLIELMI DETACHABLE COIL (GDC)
K031049 · HCG
Boston Scientific, Target
Neurology · 121d
Cleared Aug 01, 2003
MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
K031578 · HCG
Micrus Corp.
Neurology · 73d
Cleared Jul 21, 2003
TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
K024377 · QJQ
Kalaco Scientific, Inc.
Neurology · 202d
Cleared Jul 21, 2003
SAPPHIRE DETACHABLE COIL SYSTEM
K030392 · HCG
Micro Therapeutics, Inc.
Neurology · 166d
Cleared Jul 18, 2003
PROVIDENCE MOLDING HELMET
K030669 · MVA
Northeast Orthotics and Prothetics, Inc.
Neurology · 137d
Cleared Jul 10, 2003
CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE,...
K031482 · GXH
Cryomedical Instruemts , Ltd.
Neurology · 59d
Cleared Jun 24, 2003
ASYRA
K023355 · GZO
Galloway Technologies, LLC
Neurology · 260d
Cleared Jun 20, 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE...
K030963 · HCG
Cordis Neurovascular, Inc.
Neurology · 85d
Cleared Jun 20, 2003
TEMPORARY TITANIUM ANEURYSM CLIP
K031468 · HCH
Cardinalhealth
Neurology · 42d
Cleared Jun 17, 2003
TENS PRO 900
K023726 · GZJ
Acumed Medical Supplies , Ltd.
Neurology · 223d
Cleared Jun 13, 2003
LEKTROGEL, MODEL LK3001
K030887 · GYB
Inmed Ltda.
Neurology · 84d
Cleared Jun 11, 2003
VECTORVISION FLUORO3D
K024192 · HAW
Brainlab AG
Neurology · 203d
Cleared Jun 11, 2003
ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES
K030800 · GXY
Eletromed, Inc.
Neurology · 90d
Cleared Jun 06, 2003
MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
K030332 · NYN
Bionicare Medical Technologies, Inc.
Neurology · 126d
Cleared Jun 04, 2003
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · JXG
Aesculap, Inc.
Neurology · 41d
Cleared Jun 02, 2003
STRYKER NAVIGATION SYSTEM-KNEE MODULE
K022579 · HAW
Stryker Leibinger
Neurology · 301d
Cleared May 23, 2003
NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204
K030827 · HAW
Orthosoft, Inc.
Neurology · 70d
Cleared May 21, 2003
SPIN DOWN RAPIDFLAP
K031034 · GXN
Walter Lorenz Surgical, Inc.
Neurology · 50d
Cleared May 20, 2003
BODY CLOCK TENS N' TONE
K022849 · GZJ
Body Clock Health Care, Ltd.
Neurology · 266d
Cleared May 15, 2003
SURGISIS NERVE CUFF
K031069 · JXI
Cook Biotech, Inc.
Neurology · 41d
Cleared May 14, 2003
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
K031086 · GWM
Integra Neurosciences
Neurology · 37d
Cleared May 14, 2003
CODMAN BACTISEAL BARIUM STRIPED CATHETERS
K031123 · HCA
Codman & Shurtleff, Inc.
Neurology · 35d
Cleared May 14, 2003
OLYMPIC CFM 6000
K031149 · OMA
Olympic Medical Corp.
Neurology · 34d
Cleared May 14, 2003
MATRIX STRETCH RESISTANT DETACHABLE COIL
K031168 · HCG
Boston Scientific, Target
Neurology · 30d