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: Cleared only ×
175,230 results
1297–1320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2026
BreathePal Bilevel (GFM50-MD2201)
K252078 · MNS
Compal Electronics, Inc.
Anesthesiology · 258d
Cleared Mar 17, 2026
enCore Impression Material
K251926 · SHI
Encore Guards
Dental · 267d
Cleared Mar 16, 2026
Ulike Reglow Light Therapy Device (UM10)
K260511 · OHS
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 27d
Cleared Mar 16, 2026
SINEFIX
K254176 · MBI
BAAT Medical Products B.V.
Orthopedic · 83d
Cleared Mar 16, 2026
LED Light Therapy Mask (Models: T2, RLD10)
K254079 · OHS
Shenzhen Desida Technology Co., Ltd.
General & Plastic Surgery · 88d
Cleared Mar 16, 2026
CarboClear® Posterior Cervical Screw System
K254045 · NKG
CarboFix Orthopedics , Ltd.
Orthopedic · 89d
Cleared Mar 16, 2026
Data Analysis Facilitation Suite (DAFS)
K253944 · QIH
Voronoi Health Analytics Incorporated
Radiology · 96d
Cleared Mar 16, 2026
APTUS Shoulder Proximal Humerus System, PentaLock 3.5
K253916 · HRS
Medartis AG
Orthopedic · 98d
Cleared Mar 16, 2026
Lifemotion Disposable Membrane Oxygenator
K253838 · DTZ
Lifemotion Medical Technology Co., Ltd.
Cardiovascular · 105d
Cleared Mar 16, 2026
Healgen® Accurate Oral Fluid Drug Test
K253705 · DJC
Healgen Scientific, LLC
Toxicology · 112d
Cleared Mar 16, 2026
Millipede System
K253590 · NRY
Perfuze, Ltd.
Neurology · 119d
Cleared Mar 16, 2026
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
K253447 · GXR
Orthocon, Inc.
Neurology · 165d
Cleared Mar 16, 2026
Stealth AXiS™ ENT clinical application
K253395 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 167d
Cleared Mar 16, 2026
ZENEX Implant System_Short (R-System)
K253334 · DZE
Izenimplant Co., Ltd.
Dental · 167d
Cleared Mar 16, 2026
Sonio Detect (v3)
K252433 · IYN
Sonio
Radiology · 227d
Cleared Mar 16, 2026
SurgiCount+ System
K252282 · PBZ
Stryker Instruments
Obstetrics & Gynecology · 237d
Cleared Mar 16, 2026
DCwire Micro-guidewire
K252122 · MOF
Shanghai Achieva Medical Suzhou Co.,...
Neurology · 252d
Cleared Mar 15, 2026
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001)
K253581 · IKT
Technomed Europe
Neurology · 118d
Cleared Mar 13, 2026
Amplatzer™ Trevisio™ Intravascular Delivery System
K260499 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Mar 13, 2026
TheraSphere 360™ Y-90 Management Platform
K260479 · LLZ
Boston Scientific Corporation
Radiology · 28d
Cleared Mar 13, 2026
New Wave System
K260455 · GWQ
Zeto, Inc.
Neurology · 30d
Cleared Mar 13, 2026
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
K260147 · BTA
Shenzhen Kingboom Technology Co., Ltd.
Ear, Nose, Throat · 52d
Cleared Mar 13, 2026
Aquilion ServeSP (TSX-307B) V2.0
K260078 · JAK
Canon Medical Systems Corporation
Radiology · 60d
Cleared Mar 13, 2026
Embrace Neonatal MRI System
K254277 · LNH
Aspect Imaging, Ltd.
Radiology · 73d