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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39505–39528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2013
ISCHEMA VIEW RAPID
K121447 · LLZ
Ischemaview, Inc.
Radiology · 507d
Cleared Oct 04, 2013
INNER PEACE
K122800 · HIR
Kamabry, Inc., Dba Inner Peace For Women
Gastroenterology & Urology · 387d
Cleared Oct 04, 2013
PATHFAST CK-MB-II CALIBRATORS
K130628 · JIT
Mitsubishi Chemical Medience Corporation
Chemistry · 210d
Cleared Oct 04, 2013
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
K131709 · LRC
Arthrocare Corp.
Ear, Nose, Throat · 115d
Cleared Oct 04, 2013
AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G,...
K131820 · HRX
Care Fusion
Orthopedic · 106d
Cleared Oct 04, 2013
MICROPLEX COIL SYSTEM (MCS)
K131948 · HCG
MicroVention, Inc.
Neurology · 99d
Cleared Oct 04, 2013
XPRESS MULTI-SINUS DILATION TOOL
K132440 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 59d
Cleared Oct 04, 2013
VITAHEAT PATIENT WARMING SYSTEM
K132454 · DWJ
Vitaheat Medical, LLC
Cardiovascular · 59d
Cleared Oct 04, 2013
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
K132645 · GAD
Medtronic, Inc.
General & Plastic Surgery · 42d
Cleared Oct 04, 2013
STAXX IBL SYSTEM
K132719 · MAX
Spine Wave, Inc.
Orthopedic · 35d
Cleared Oct 04, 2013
S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K132768 · IYN
Sonoscape Company Limited
Radiology · 30d
Cleared Oct 04, 2013
UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM
K132861 · IYN
Samsung Medison Co., Ltd.
Radiology · 22d
Cleared Oct 04, 2013
SMARTSITE VIALSHIELD
K132863 · LHI
Yukon Medical, LLC
General Hospital · 22d
Cleared Oct 04, 2013
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
K132905 · BRZ
Arteriocyte Medical Systems, Inc.
General Hospital · 18d
Cleared Oct 03, 2013
AMCAD-UT DETECTION MODEL 2.0
K122536 · LLZ
Lin & Associates, LLC
Radiology · 409d
Cleared Oct 03, 2013
MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
K122557 · KGO
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 407d
Cleared Oct 03, 2013
CLEANSER ROOT CANAL
K130180 · KJJ
Cerkamed Wojciech Pawlowski
Dental · 251d
Cleared Oct 03, 2013
OCCLUSION PERFUSION CATHETER
K130525 · DQY
Advanced Catheter Therapies, Inc.
Cardiovascular · 217d
Cleared Oct 03, 2013
DISPOSABLE SILICONE FOLEY CATHETER
K130908 · EZL
Guangdong Baihe Medical Technology...
Gastroenterology & Urology · 185d
Cleared Oct 03, 2013
FINGERTIP PULSE OXIMETER
K130947 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 182d
Cleared Oct 03, 2013
LEDEX
K131042 · EBZ
Dentmate Technology Co. , Ltd.
Dental · 171d
Cleared Oct 03, 2013
NEO KNEE SYSTEM
K131368 · JWH
Pipeline Orthopedics
Orthopedic · 143d
Cleared Oct 03, 2013
ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW,...
K131435 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 136d
Cleared Oct 03, 2013
MODIFIED FLOWGATE BALLOON GUIDE CATHETER
K131492 · DQY
Concentric Medical, Inc.
Cardiovascular · 133d