FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
17329–17352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2021
Trinias
K203535 · OWB
Shimadzu Corporation Medical Systems
Radiology · 146d
Cleared Apr 28, 2021
Medical Mask
K210020 · FXX
Zhende Medical Co., Ltd.
General Hospital · 114d
Cleared Apr 28, 2021
Astroglide X Silicone Personal Lubricant
K210242 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 89d
Cleared CT Apr 28, 2021
Titan SGS
K210278 · GDW
Standard Bariatrics
General & Plastic Surgery · 86d
Cleared Apr 28, 2021
Plato 17 Microcatheter
K210601 · DQY
Scientia Vascular, LLC
Neurology · 58d
Cleared Apr 28, 2021
Oral/Enteral Syringe
K210621 · PNR
Ningbo Tianyi Medical Appliance Co.,...
Gastroenterology & Urology · 57d
Cleared Apr 28, 2021
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse...
K210925 · GEX
Boston Scientific
Gastroenterology & Urology · 30d
Cleared Apr 28, 2021
AMX Navigate
K210982 · IZL
Ge Medical Systems, LLC
Radiology · 27d
Cleared Apr 28, 2021
1717FCC
K210985 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Apr 27, 2021
Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device
K191951 · NFO
Avazzia, Inc.
Neurology · 645d
Cleared Apr 27, 2021
STARband, STARlight, St. Louis Band
K203098 · OAN
Orthomerica Products, Inc.
Neurology · 195d
Cleared Apr 27, 2021
Responsive Arthroscopy Thunderbolt System
K203121 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 193d
Cleared Apr 27, 2021
AccelX Abutments
K203240 · NHA
Integrated Dental Systems, LLC
Dental · 175d
Cleared Apr 27, 2021
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
K210609 · LPL
Vp Optics
Ophthalmic · 57d
Cleared Apr 27, 2021
Stone Retrieval Balloon Catheter
K210660 · GCA
Anrei Medical (Hangzhou) Co., Ltd.
Gastroenterology & Urology · 54d
Cleared Apr 27, 2021
Resonic Rapid Acoustic Pulse Device
K210964 · GEX
Soliton, Inc.
General & Plastic Surgery · 27d
Cleared Apr 27, 2021
Safety Trocar Cannula
K211072 · KNT
Boston Scientific Corporation
Gastroenterology & Urology · 15d
Cleared Apr 26, 2021
VIVACE Electrosurgical Device
K193070 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 539d
Cleared Apr 26, 2021
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit,...
K200260 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 448d
Cleared Apr 26, 2021
ERISE Laser handpiece
K202258 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 259d
Cleared Apr 26, 2021
Vital Sign Monitoring Sensor (Model :XK300)
K202464 · DRT
Xandar Kardian, Inc.
Cardiovascular · 242d
Cleared Apr 26, 2021
Surgical Mask
K202647 · FXX
Ningbo Green Textile Co., Ltd.
General Hospital · 227d
Cleared Apr 26, 2021
MicroDose Injector
K203264 · FMF
Medone Surgical, Inc.
Ophthalmic · 172d
Cleared Apr 26, 2021
Powder Free Blue Nitrile Examination Glove
K203512 · LZA
Vip Glove Sdn Bhd
General Hospital · 147d