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: Cleared only ×
175,820 results
25081–25104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2018
DENV Detect NS1 ELISA
K181473 · QCU
InBios International, Inc.
Microbiology · 84d
Cleared Aug 27, 2018
Tranquil Interbody System
K181483 · MAX
Nexus Spine, LLC
Orthopedic · 83d
Cleared Aug 27, 2018
DemeTECH DemeDIOX absorbable surgical suture
K181582 · NEW
Demetech Corporation
General & Plastic Surgery · 73d
Cleared Aug 24, 2018
Double Medical Femoral Nail System
K172830 · HSB
Double Medical Technology, Inc.
Orthopedic · 340d
Cleared Aug 24, 2018
EPINAUT
K173541 · BSO
Imedicom Co., Ltd.
Anesthesiology · 282d
Cleared Aug 24, 2018
AcuSnare Polypectomy Snare
K173673 · FDI
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 267d
Cleared Aug 24, 2018
IOLMaster 700
K173771 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 256d
Cleared Aug 24, 2018
CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER...
K173978 · DQK
Biosense Webster, Inc.
Cardiovascular · 238d
Cleared Aug 24, 2018
NC TREK™ RX Coronary Dilatation Catheter
K180040 · LOX
Abbott Vascular
Cardiovascular · 231d
Cleared Aug 24, 2018
Firebird® Spinal Fixation Systems: Firebird System
K180179 · NKB
Orthofix, Inc.
Orthopedic · 213d
Cleared Aug 24, 2018
CancelleX Porous Titanium Lumbar Interbody Device
K180373 · MAX
Xenco Medical, LLC
Orthopedic · 193d
Cleared Aug 24, 2018
APTUS CMC-I Fusion Plate System
K181009 · HRS
Medartis AG
Orthopedic · 129d
Cleared Aug 24, 2018
AOS Small Fragment Plating System Lite
K181035 · HRS
Advanced Orthopaedic Solutions, Inc....
Orthopedic · 128d
Cleared Aug 24, 2018
Solitaire 2 and Solitaire Platinum Revascularization Device
K181060 · POL
Medtronic Neurovascular
Neurology · 123d
Cleared Aug 24, 2018
NuVasive Brigade Lateral System
K181386 · OVD
Nu Vasive, Incorporated
Orthopedic · 91d
Cleared Aug 24, 2018
RadiForce GX560, GX560-AR
K181609 · PGY
Eizo Corporation
Radiology · 66d
Cleared Aug 24, 2018
EasyMax BT Self-Monitoring Blood Glucose System
K182057 · NBW
Eps Bio Technology Corp.
Chemistry · 24d
Cleared Aug 23, 2018
Z-CAD smile
K170050 · EIH
Metoxit AG
Dental · 595d
Cleared Aug 23, 2018
Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
K173657 · EZL
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared Aug 23, 2018
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
K173732 · DFH
The Binding Site Group , Ltd.
Immunology · 260d
Cleared Aug 23, 2018
Smylic Invisible Clear Aligners
K173784 · NXC
Smylio, Inc.
Dental · 253d
Cleared Aug 23, 2018
GMK Sphere - Kinematic Alignment
K173890 · JWH
Medacta International S.A.
Orthopedic · 245d
Cleared Aug 23, 2018
Freespira
K180173 · HCC
Palo Alto Health Sciences, Inc.
Neurology · 213d
Cleared Aug 23, 2018
Stat Profile Prime Plus Analyzer System
K180186 · GGZ
Nova Biomedical Corporation
Chemistry · 212d