FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,922 results
217–240 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 09, 2026
PINKSLIP Water-Based Personal Lubricant and Moisturizer
K261177 · NUC
PINKSLIP, LLC
Obstetrics & Gynecology · 90d
Cleared Jul 09, 2026
DIA-CEM
K261166 · EMA
DiaDent Group International
Dental · 91d
Cleared Jul 09, 2026
HYDROS Robotic System (HY1000)
K260723 · PZP
Procept Biorobotics
Gastroenterology & Urology · 126d
Cleared Jul 09, 2026
MedSource QuickSafe™ Safety IV Catheter
K260539 · FOZ
MedSource Labs, LLC
General Hospital · 142d
Cleared Jul 09, 2026
LifeLens Physiological Monitor
K260157 · DSH
LifeLens Technologies, Inc.
Cardiovascular · 170d
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