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
18649–18672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2020
VeriFixx™ Small Bone Implant
K202777 · HTY
Armis Biopharma, Inc.
Orthopedic · 56d
Cleared Nov 17, 2020
Disposable Trocar
K202931 · GCJ
Wuxi Shukang Medical Appliance Co., Ltd.
General & Plastic Surgery · 49d
Cleared Nov 16, 2020
Telio CAD Abutment Solutions- extra systems
K193193 · NHA
Ivoclar Vivadent, AG
Dental · 363d
Cleared Nov 16, 2020
Freeprint denture
K200461 · EBI
Detax GmbH & Co. KG
Dental · 265d
Cleared Nov 16, 2020
Sientra OPUS Silicone Gel Breast Implant Sizer
K200706 · MRD
Sientra, Inc.
General & Plastic Surgery · 243d
Cleared Nov 16, 2020
Cordiana Dx16
K201060 · DQK
Cordiana Medical Informatics AG
Cardiovascular · 209d
Cleared Nov 16, 2020
EVOS Large Fragment Plating System
K201918 · HRS
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Nov 16, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64...
K202343 · LTT
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Nov 16, 2020
TiUltra Implants and Xeal Abutments
K202344 · DZE
Nobel Biocare AB
Dental · 90d
Cleared Nov 16, 2020
Ion Endoluminal System
K202370 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 89d
Cleared Nov 16, 2020
Avid CT2
K202490 · IPF
Vision Quest Industries Inc./Dba VQ...
Neurology · 77d
Cleared Nov 16, 2020
Nd: YAG Laser Therapy Systems HM-YL900
K202758 · GEX
Shangdong Huamei Technology Co., Ltd.
General & Plastic Surgery · 56d
Cleared Nov 16, 2020
Circular Fixation with Balanced Cable Transport
K202762 · KTT
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Nov 16, 2020
M.U.S.T. MINI Posterior Cervical Screws System
K203149 · NKG
Medacta International S.A.
Orthopedic · 25d
Cleared Nov 14, 2020
Apogee
K200401 · NFB
Incoba Ltd D/B/A Dynaris
Anesthesiology · 270d
Cleared Nov 13, 2020
Kerecis Gingiva Graft
K192612 · NPL
Kerecis Limited
Dental · 420d
Cleared Nov 13, 2020
NEUWAVE Microwave Ablation System and Accessories
K200081 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 303d
Cleared Nov 13, 2020
Astroglide Organix Gel
K200239 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 287d
Cleared Nov 13, 2020
SpeediCath Compact Set
K200820 · GBM
Coloplast
Gastroenterology & Urology · 228d
Cleared Nov 13, 2020
SINGLE USE MANOMETER
K201666 · CAP
Flexicare Medical Limited.
Anesthesiology · 147d
Cleared Nov 13, 2020
CoroFlow Cardiovascular System
K201881 · DQK
Coroventis Research AB
Cardiovascular · 129d
Cleared Nov 13, 2020
Ceramir Restore QuikCap
K201937 · EMA
Doxa Dental AB
Dental · 123d
Cleared Nov 13, 2020
Venue
K202132 · IYN
GE Medical Systems Ultrasound and...
Radiology · 105d
Cleared Nov 13, 2020
VersaLoop Anchor System
K202178 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 101d