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
28201–28224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2017
Nihon Kohden Wireless Input Unit WEE-1200
K171124 · GWQ
Nihon Kohden Corporation
Neurology · 130d
Cleared Aug 25, 2017
Hexagen Derm
K171191 · FRO
Global Health Solutions, LLC
General & Plastic Surgery · 123d
Cleared Aug 25, 2017
Sapphire Sets
K171346 · MRZ
Icu Medical
General Hospital · 109d
Cleared Aug 25, 2017
Sirius MRI Marker NS
K171487 · KXK
C4 Imaging, LLC
Radiology · 95d
Cleared Aug 25, 2017
OTIS Optical Coherence Tomography System
K171560 · NQQ
Perimeter Medical Imaging, Inc.
General & Plastic Surgery · 87d
Cleared Aug 25, 2017
SKR 3000
K171716 · MQB
Konica Minolta, Inc.
Radiology · 77d
Cleared Aug 25, 2017
Catalys Precision Laser System
K172002 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 53d
Cleared Aug 25, 2017
Hi-Torque Command 18 Guide Wire
K172073 · DQX
Abbott Vascular
Cardiovascular · 46d
Cleared Aug 25, 2017
Standard Supreme Sterilization Wrapper
K172207 · FRG
Standard Textile Co., Inc.
General Hospital · 35d
Cleared Aug 25, 2017
VMA™ System version 3.0
K172327 · LLZ
Ortho Kinematics, Inc.
Radiology · 24d
Cleared Aug 24, 2017
Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve -...
K170367 · MNT
Fisher and Paykel Healthcare Limited
Anesthesiology · 199d
Cleared Aug 24, 2017
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive...
K170750 · MUJ
Brainlab AG
Radiology · 164d
Cleared Aug 24, 2017
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication
K170982 · MEA
Smiths Medical Ads, Inc.
General Hospital · 143d
Cleared Aug 24, 2017
RS80A Diagnostic Ultrasound System
K171048 · IYN
Samsung Medison Co., Ltd.
Radiology · 139d
Cleared Aug 24, 2017
OrthoPediatrics Titanium PediPlates® System
K171173 · HRS
OrthoPediatrics Corp.
Orthopedic · 125d
Cleared Aug 24, 2017
Entrada™ hip stem
K171249 · MEH
Ortho Development Corporation
Orthopedic · 118d
Cleared Aug 24, 2017
Fixone Biocomposite Anchor
K171299 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 113d
Cleared Aug 24, 2017
NxStage System One
K171331 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 108d
Cleared Aug 24, 2017
Stryker Self-Punching ICONIX
K171465 · MBI
Stryker
Orthopedic · 98d
Cleared Aug 24, 2017
MagnetOs Putty
K171563 · MQV
Kuros Biosciences B.V
Orthopedic · 86d
Cleared Aug 24, 2017
Liver Access and Biopsy Sets
K171853 · DYB
Cook Incorporated
Cardiovascular · 64d
Cleared Aug 24, 2017
F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer...
K171865 · HGM
Farus, LLC
Obstetrics & Gynecology · 63d
Cleared Aug 24, 2017
VenaCure EVLT NeverTouch Procedure Kit
K171921 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 58d
Cleared Aug 24, 2017
PRECICE UNYTE System
K172061 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 48d