FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
6289–6312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
K241081 · OBO
Topcon Corporation
Ophthalmic · 89d
Cleared Jul 17, 2024
Rayvolve
K240845 · QBS
Azmed Sas
Radiology · 112d
Cleared Jul 17, 2024
Vitrea Software Package, VSTP-002A V2.0
K240705 · LLZ
Canon Medical Systems Corporation
Radiology · 125d
Cleared Jul 17, 2024
S.I.N. Dental Implant System
K240609 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 135d
Cleared Jul 17, 2024
Sonata Transcervical Fibroid Ablation System 2.2
K240503 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 147d
Cleared Jul 17, 2024
ACIST RXi System (016616)
K233904 · DXO
Acist Medical Systems, Inc.
Cardiovascular · 219d
Cleared Jul 16, 2024
SAFElife™ Fentanyl Urine Home Test (Cassette)
K241741 · NGL
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Jul 16, 2024
Finesse Injectable™ PTA Balloon Dilatation Catheter
K241740 · LIT
Summa Therapeutics
Cardiovascular · 29d
Cleared Jul 16, 2024
RadiForce RX670
K241441 · PGY
Eizo Corporation
Radiology · 55d
Cleared Jul 16, 2024
Light Cure Adhesive
K241056 · KLE
Sincera Technology (Changchun) Co., Ltd.
Dental · 89d
Cleared Jul 16, 2024
CrossRoads Modular Tray System
K241050 · KCT
Crossroads Extremity Systems
General Hospital · 90d
Cleared Jul 16, 2024
Swoop® Portable MR Imaging® System
K240944 · LNH
Hyperfine, Inc.
Radiology · 102d
Cleared Jul 16, 2024
Electric Scooter (M2085, S2091)
K240272 · INI
Guangdong Prestige Technology Co., Ltd.
Physical Medicine · 167d
Cleared Jul 16, 2024
Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible...
K233778 · FGB
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 232d
Cleared Jul 15, 2024
NeuroLF (Basic)
K241751 · KPS
Positrigo AG
Radiology · 27d
Cleared Jul 15, 2024
Endoscopic Applicator, 41 cm
K241739 · GCJ
Micromedics, Inc.
General & Plastic Surgery · 28d
Cleared Jul 15, 2024
BellaTek Bars
K241032 · NHA
Biomet 3i, LLC
Dental · 90d
Cleared Jul 15, 2024
FAQ™ (102)
K240616 · PAY
Foreo, Inc.
Physical Medicine · 132d
Cleared Jul 15, 2024
Huxley SANSA Home Sleep Apnea Test (1000-00)
K240285 · MNR
Huxley Medical
Anesthesiology · 165d
Cleared Jul 15, 2024
RFG-01
K240178 · PBX
Zimmer Medizinsysteme GmbH
General & Plastic Surgery · 174d
Cleared Jul 15, 2024
CM00622 LINC Skin Closure System (CM00622 LINC)
K233460 · OMD
Connexicon Medical , Ltd.
General & Plastic Surgery · 266d
Cleared Jul 15, 2024
CM005 Standard (CM005)
K233458 · MPN
Connexicon Medical , Ltd.
General & Plastic Surgery · 266d
Cleared Jul 15, 2024
Avantik VTM
K233449 · JSM
Hanchang Medic Co., Ltd. (Han Chang...
Microbiology · 269d
Cleared Jul 13, 2024
Omnifix Syringe NRFit
K241385 · QEH
B.Braun Medical, Inc.
General Hospital · 59d