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
23353–23376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2019
FlareHawk Interbody Fusion System
K183184 · MAX
Integrity Implants, Inc.
Orthopedic · 135d
Cleared Apr 03, 2019
HORIZON TMS Therapy System with Navigation
K183376 · OBP
Magstim Company, Ltd.
Neurology · 118d
Cleared Apr 03, 2019
iFuse Implant System®
K190230 · OUR
SI-BONE, Inc.
Orthopedic · 56d
Cleared Apr 03, 2019
Karma® Fixation System
K190289 · OWI
Spinal Elements, Inc.
Orthopedic · 51d
Cleared Apr 03, 2019
VITROS XT Chemistry Products GLU-Ca Slides
K190520 · CGA
Ortho-Clinical Diagnostics, Inc.
Chemistry · 30d
Cleared Apr 03, 2019
Bio-Medicus Insertion Kit
K190557 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Apr 03, 2019
Monster® Screw System
K190586 · HWC
Paragon 28, Inc.
Orthopedic · 28d
Cleared Apr 02, 2019
Zimmer Biomet Ceramic Heads
K181171 · LZO
Zimmer, Inc.
Orthopedic · 335d
Cleared Apr 02, 2019
FUJIFILM Endoscope Model EG-740N
K182836 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 175d
Cleared Apr 02, 2019
Ilumien Optis, Optis Integrated, Optis Mobile
K183320 · NQQ
St. Jude Medical (Now Abbott Medical)
Cardiovascular · 123d
Cleared Apr 02, 2019
AcQMap High Resolution Imaging and Mapping System
K190131 · DQK
Acutus Medical, Inc.
Cardiovascular · 64d
Cleared Apr 02, 2019
ARIETTA 50
K190248 · IYN
Hitachi Healthcare Americas
Radiology · 54d
Cleared Apr 01, 2019
Le'Pen
K181597 · EBZ
Kmihh, Ltd.
Dental · 287d
Cleared Apr 01, 2019
Bencox Mirabo Cup Multi Hole
K182221 · LPH
Corentec Co., Ltd.
Orthopedic · 228d
Cleared Apr 01, 2019
Vantage Total Ankle Flat Cut Talar Components
K183343 · HSN
Exactech, Inc.
Orthopedic · 119d
Cleared Apr 01, 2019
CUSA Clarity Ultrasonic Surgical Aspirator System
K190180 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 59d
Cleared Apr 01, 2019
Microperimeter MP-3, Microperimeter MP-3 Type S
K190198 · HKI
Nidek Co., Ltd.
Ophthalmic · 56d
Cleared Apr 01, 2019
7400 Ultrasound Systems
K190447 · IYN
Navigant Consulting - on Behalf of...
Radiology · 35d
Cleared Apr 01, 2019
DBSWIN and VISTAEASY Imaging Software
K190629 · LLZ
Durr Dental SE
Radiology · 20d
Cleared Mar 29, 2019
3880 MRI Patient Monitoring System
K180903 · MWI
Iradimed Corporation
Cardiovascular · 357d
Cleared Mar 29, 2019
Reflect Implant System
K180924 · DZE
Ids - Integrated Dental Systems
Dental · 354d
Cleared Mar 29, 2019
Loop System
K181352 · DQA
Spry Health, Inc.
Cardiovascular · 311d
Cleared Mar 29, 2019
Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
K181770 · LKF
Cook Incorporated
Obstetrics & Gynecology · 269d
Cleared Mar 29, 2019
AggreGuide A-100 ADP
K181777 · JOZ
Aggredyne, Inc.
Hematology · 269d