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
25105–25128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2018
ADVIA Centaur Herpes-1 IgG
K181333 · MXJ
Biokit, S.A.
Microbiology · 94d
Cleared Aug 23, 2018
ADVIA Centaur Herpes-2 IgG
K181334 · MYF
Biokit, S.A.
Microbiology · 94d
Cleared Aug 23, 2018
SpyGlass DS and DS II Direct Visualization System
K181439 · FBN
Boston Scientific Corporation
Gastroenterology & Urology · 83d
Cleared Aug 23, 2018
GMK Sphere CR Tibial Inserts
K181635 · JWH
Medacta International S.A.
Orthopedic · 63d
Cleared Aug 23, 2018
MyoSure XL Tissue Removal Device for Fluent
K181974 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 30d
Cleared Aug 22, 2018
Non-invasive blood pressure measurement systems
K173024 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 328d
Cleared Aug 22, 2018
NIM PAK Needle
K180542 · PDQ
Boston Endo Surgical Tech,
Neurology · 174d
Cleared Aug 22, 2018
GrandioSO x-tra
K181312 · EBF
Voco GmbH
Dental · 97d
Cleared Aug 22, 2018
autoLog IQ Autotransfusion System
K181954 · CAC
Medtronic Perfusion Systems
Cardiovascular · 30d
Cleared Aug 21, 2018
Reusable NIBP Cuff
K173197 · DXQ
Orantech, Inc.
Cardiovascular · 323d
Cleared Aug 21, 2018
Confidence Blood Glucose Monitoring System
K173658 · NBW
Applied Biomedical, LLC
Chemistry · 265d
Cleared Aug 21, 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K180698 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 158d
Cleared Aug 21, 2018
exGraft, exGraft Carbon ePTFE Vascular Grafts
K180957 · DSY
Peca Labs
Cardiovascular · 131d
Cleared Aug 21, 2018
Fever Scout
K181013 · FLL
VivaLNK, Inc.
General Hospital · 126d
Cleared Aug 21, 2018
H. PYLORI QUIK CHEK
K181379 · LYR
Techlab, Inc.
Microbiology · 89d
Cleared Aug 21, 2018
H. PYLORI CHEK™
K181400 · LYR
Techlab, Inc.
Microbiology · 84d
Cleared Aug 21, 2018
ATEC Cervical Spacer System
K181435 · ODP
Alphatec Spine, Inc.
Orthopedic · 81d
Cleared Aug 21, 2018
SIMPLYSTRONG, SIMPLYEZEE
K181791 · GCJ
Genicon, Inc.
General & Plastic Surgery · 47d
Cleared Aug 21, 2018
Medtronic Model 5392 External Pulse Generator (EPG)
K181973 · DTE
Medtronic, Inc.
Cardiovascular · 28d
Cleared Aug 21, 2018
MIDAScope and Introducer Kit, and MIDASystem
K181982 · HRX
Intravu, Inc.
General & Plastic Surgery · 27d
Cleared Aug 21, 2018
PENTAX Medical Endoscopic Ultrasound System
K182004 · ODG
Pentax of America, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 20, 2018
BD Vacutainer Eclipse Signal Blood Collection Needle
K170824 · FMI
Becton, Dickinson and Company
General Hospital · 518d
Cleared Aug 20, 2018
Young INFINITY Cordless Handpiece System
K171377 · EKX
Young Dental Manufacturing Co. 1, LLC
Dental · 467d
Cleared Aug 20, 2018
BEXCORE Breast Biopsy System, Biopsy Needle
K171890 · KNW
Medical Park Co., Ltd.
General & Plastic Surgery · 420d