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
19465–19488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2020
Arm-Type Fully Automatic Digital Blood Pressure Monitor
K200649 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 144d
Cleared CT Aug 03, 2020
EyeArt
K200667 · PIB
Eyenuk, Inc.
Ophthalmic · 143d
Cleared Aug 03, 2020
Glaucoma Module
K200954 · NFJ
Topcon Healthcare Solutions, Inc.
Ophthalmic · 116d
Cleared Jul 31, 2020
Flex Fit
K190790 · EBI
Dk Mungyo Corporation
Dental · 492d
Cleared Jul 31, 2020
Kendall NPWT Incision Management Dressing Kit
K191101 · OMP
Cardinalhealth
General & Plastic Surgery · 463d
Cleared Jul 31, 2020
I Do
K192294 · DZE
I DO Biotech Co., Ltd.
Dental · 343d
Cleared Jul 31, 2020
Cyber Blade
K192499 · GCJ
SIDAM S.r.l.
Gastroenterology & Urology · 324d
Cleared Jul 31, 2020
Carto Octaray Mapping Catheter with Trueref Technology
K193237 · MTD
Biosense Webster, Inc.
Cardiovascular · 249d
Cleared Jul 31, 2020
P pro Crown & Bridge
K200039 · EBG
Deltamed GmbH
Dental · 205d
Cleared Jul 31, 2020
xPORT 304 (miCOR) System Lens Fragmentation System
K200584 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 147d
Cleared Jul 31, 2020
Navigation Enabled Intruments
K200791 · OLO
Medos International SARL
Orthopedic · 127d
Cleared Jul 31, 2020
BEAR and BEAR mini
K200803 · NFO
Foreo, Inc.
Neurology · 126d
Cleared Jul 31, 2020
VibrantVue Scleral Saline
K201069 · MRC
Dry Eye Innovations, LLC
Ophthalmic · 100d
Cleared Jul 31, 2020
CORBEL Spacers
K201087 · OVD
Globus Medical, Inc.
Orthopedic · 99d
Cleared Jul 31, 2020
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for...
K201442 · LAF
Diatron Group
Toxicology · 60d
Cleared Jul 31, 2020
Reprocessed Endoscopic Trocars and Sleeves
K201511 · NLM
Stryker Sustainability Solutions
General & Plastic Surgery · 56d
Cleared Jul 31, 2020
Liver Incytes, Model 1005
K201597 · IYO
Sonic Incytes
Radiology · 49d
Cleared Jul 31, 2020
BiPad Hand Activated, Disposable Bipolar Electrocautery Cords
K201833 · GEI
Bipad Surgical, Inc.
General & Plastic Surgery · 29d
Cleared Jul 31, 2020
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2...
K201837 · PEW
Neotract, Inc.
Gastroenterology & Urology · 29d
Cleared Jul 31, 2020
Clear Guide SCENERGY
K201898 · JAK
Clear Guide Medical
Radiology · 29d
Cleared Jul 31, 2020
Cemented Origin Hip Stem
K201951 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 18d
Cleared Jul 30, 2020
Joimax Intracs System
K192663 · OLO
Joimax GmbH
Orthopedic · 309d
Cleared Jul 30, 2020
AI-Rad Companion Prostate MR
K193283 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 246d
Cleared Jul 30, 2020
MY01 Continuous Compartmental Pressure Monitor
K193321 · LXC
MY01, Inc.
Orthopedic · 241d