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

Filters: Cleared only ×
175,820 results
23065–23088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2019
Hysteroscope System
K181545 · HIH
Shanghai AnQing Medical Instrument...
Obstetrics & Gynecology · 332d
Cleared May 10, 2019
Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet...
K182612 · LZA
Zibo Yahao Supplies Co., Ltd.
General Hospital · 231d
Cleared May 10, 2019
Wallace Dual Lumen Oocyte Recovery System
K182959 · MQE
CooperSurgical, Inc.
Obstetrics & Gynecology · 197d
Cleared May 10, 2019
Triangle System
K183319 · DXH
AliveCor, Inc.
Cardiovascular · 161d
Cleared May 10, 2019
Vanguard Complete Knee System
K183583 · JWH
Zimmer, Inc.
Orthopedic · 140d
Cleared May 10, 2019
SteriStay
K190027 · ORC
Toul Meditech AB
General & Plastic Surgery · 123d
Cleared May 10, 2019
Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550...
K190173 · LEJ
Jk Holding GmbH
General & Plastic Surgery · 98d
Cleared May 10, 2019
GenePOC Carba
K190275 · PMY
Genepoc, Inc.
Microbiology · 91d
Cleared May 10, 2019
Therm-X
K190854 · IRP
Zenith Technical Innovations
Physical Medicine · 38d
Cleared May 10, 2019
6400 Ultrasound System (MyLabX6, MyLabX7)
K190989 · IYN
Esaote, S.P.A.
Radiology · 25d
Cleared May 10, 2019
ExactVu High Resolution Micro-Ultrasound System
K190995 · IYN
Exact Imaging, Inc.
Radiology · 24d
Cleared May 10, 2019
L10 LED Light Source with AIM, L11 LED Light Source with AIM
K191046 · OWN
Stryker
General & Plastic Surgery · 21d
Cleared May 09, 2019
Delta Dual Mobility System
K181491 · LZO
Lima Corporate S.P.A.
Orthopedic · 337d
Cleared May 09, 2019
TOF-Cuff monitor
K181894 · DXN
Rgb Medical Devices SA
Anesthesiology · 297d
Cleared May 09, 2019
DePuy Synthes Sterilization Container System
K181933 · KCT
Synthes (Usa) Products, LLC / Depuy...
General Hospital · 294d
Cleared May 09, 2019
ATEC IOM Accessory Instruments
K182617 · PDQ
Alphatec Spine, Inc.
Neurology · 227d
Cleared May 09, 2019
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
K183160 · JPA
Haemonetics Corporation
Hematology · 175d
Cleared May 09, 2019
Encore System
K183310 · ORY
Siesta Medical, Inc.
Dental · 161d
Cleared May 09, 2019
Unscented Menstrual Tampon
K190218 · HEB
Qingdao Youjia Hygiene Technology...
Obstetrics & Gynecology · 94d
Cleared May 09, 2019
Wingman 14C Crossing Catheter
K190393 · DQY
Reflow Medical, Inc.
Cardiovascular · 79d
Cleared May 09, 2019
CYGNUS™ Anterior Cervical Plate System
K190666 · KWQ
MiRus, LLC
Orthopedic · 55d
Cleared May 09, 2019
Rowheels Revolution 1.0
K190699 · IOR
Rowheels, Inc.
Physical Medicine · 52d
Cleared May 09, 2019
V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature...
K190917 · MLR
STERIS Corporation
General Hospital · 30d
Cleared May 09, 2019
Magic Clear Aligners
K190948 · NXC
Voodoo Manufacturing, Inc.
Dental · 28d