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: 2026–2026 ×
2,517 results
817–840 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 09, 2026
Millipede88 Access Catheter
K253901 · QJP
Perfuze, Ltd.
Neurology · 216d
Cleared Jul 09, 2026
3D-Anywhere
K253899 · LLZ
Provect.AI
Radiology · 216d
Cleared Jul 09, 2026
ScioCardio ECG Analysis Platform
K252978 · DQK
Synergen Technology Labs, LLC
Cardiovascular · 295d
Cleared Jul 08, 2026
Denture Base Resin V2
K262300 · EBI
Formlabs Ohio, Inc.
Dental · 1d
Cleared Jul 08, 2026
Electric Wheelchair
K261396 · ITI
Ningbo Resshidi Medical Devices Co.,...
Physical Medicine · 70d
Cleared Jul 08, 2026
Alians Elbow S
K261191 · HRS
Newclip Technics
Orthopedic · 86d
Cleared Jul 08, 2026
cobas CT/NG for use on the cobas 5800/6800/8800 systems
K260917 · QEP
Roche Molecular Systems, Inc.
Microbiology · 111d
Cleared Jul 08, 2026
Virtual Cone (1.0)
K260750 · MUJ
Varian Medical Systems, Inc.
Radiology · 124d
Cleared Jul 08, 2026
BlueDop Vascular Expert
K260700 · DPW
BlueDop Medical, Ltd.
Cardiovascular · 126d
Cleared Jul 08, 2026
ThermAffyx(TM) Patient Safety System
K260278 · DWJ
Stihler Electronic GmbH
Cardiovascular · 160d
Cleared Jul 08, 2026
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K260160 · SAN
bioMerieux, Inc.
Microbiology · 169d
Cleared Jul 08, 2026
C.A. Medical Interbody Fusion System
K254130 · ODP
C.A. Medical, LLC
Orthopedic · 198d
Cleared Jul 08, 2026
CXRDetectAI
K253751 · QFM
Neurocareai, Inc. (Dba Savelife.Ai)
Radiology · 225d
Cleared Jul 07, 2026
Luja Soft
K262045 · EZD
Coloplast A/S
Gastroenterology & Urology · 20d
Cleared Jul 07, 2026
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens
K261812 · MVN
Hoya Lamphun , Ltd.
Ophthalmic · 36d
Cleared Jul 07, 2026
Electric wheelchair (XW-LY007 )
K261164 · ITI
Yongkang Ruihe Metal Product Co., Ltd.
Physical Medicine · 89d
Cleared Jul 07, 2026
Mobility Scooter (R200)
K261163 · INI
Yongkang Ruihe Metal Product Co., Ltd.
Physical Medicine · 89d
Cleared Jul 07, 2026
InferOperate Suite
K260973 · QIH
Beijing Infervision Healthcare...
Radiology · 105d
Cleared Jul 07, 2026
Pulmonex II Xenon System (132-503)
K253942 · IYT
Mirion Technologies (Capintec), Inc.
Radiology · 210d
Cleared Jul 06, 2026
Plum Vagiceuticals™ Vaginal Moisturizing Suppositories
K261909 · NUC
Pcca, Inc.
Obstetrics & Gynecology · 28d
Cleared Jul 06, 2026
Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/...
K261529 · DYB
Hartman Medical Group, LLC
Cardiovascular · 59d
Cleared Jul 06, 2026
INDIRA CLOUD VIEWER
K261465 · LLZ
INDIGO TECHNOLOGIES
Radiology · 63d
Cleared Jul 06, 2026
MobileLink Acetabular Cup System – 40mm ID Inserts (various)
K261009 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 102d
Cleared Jul 06, 2026
Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)
K260122 · QRL
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 172d