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
35977–36000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2014
2.3MP Color LCD Monitor, RadiForce MX242W
K143261 · PGY
Eizo Corporation
Radiology · 8d
Cleared Nov 20, 2014
COROENT SYSTEM
K141896 · MAX
Nu Vasive, Incorporated
Orthopedic · 129d
Cleared Nov 20, 2014
FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
K142012 · PIF
Corpak Medsystems
Gastroenterology & Urology · 119d
Cleared Nov 20, 2014
LUNA INTERBODY SYSTEM
K142023 · MAX
Benvenue Medical, Inc.
Orthopedic · 118d
Cleared Nov 20, 2014
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
K142062 · DSY
Vascular Flow Technologies, Ltd.
Cardiovascular · 113d
Cleared Nov 20, 2014
AIXPLORER
K142100 · IYN
Supersonic Imagine
Radiology · 111d
Cleared Nov 20, 2014
NeumoFilt Ergo/Neumo Filt BiteOn
K142303 · BZG
Medical Respiratory Devices S.L.
Anesthesiology · 94d
Cleared Nov 20, 2014
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
K142520 · KTT
Smith & Nephew, Inc.
Orthopedic · 73d
Cleared Nov 20, 2014
PhaLinx Hammertoe System
K142585 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 66d
Cleared Nov 20, 2014
Audit MicroControls Linearity LQ Special Diabetes
K142978 · JJY
Aalto Scientific, Ltd.
Chemistry · 36d
Cleared Nov 20, 2014
Xario 200, V3.0
K143027 · IYN
Toshibamedical Systems Corporation
Radiology · 30d
Cleared Nov 20, 2014
Gel-Block 10X embolization pledgets
K143038 · KRD
Vascular Solutions, Inc.
Cardiovascular · 29d
Cleared Nov 20, 2014
MaxZero Administration Sets
K143234 · FPA
Care Fusion
General Hospital · 10d
Cleared Nov 19, 2014
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device
K133303 · JKA
Bio-Analysis, Inc.
Chemistry · 390d
Cleared Nov 19, 2014
ECVUE MAPPING SYSTEM
K140497 · DQK
Cardioinsight Technologies, Inc.
Cardiovascular · 265d
Cleared Nov 19, 2014
ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
K140569 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 258d
Cleared Nov 19, 2014
CENTERCROSS CATHETER
K140910 · DQY
Roxwood Medical, Inc.
Cardiovascular · 224d
Cleared Nov 19, 2014
FM-3000 FETAL MONITOR
K141194 · HGM
Advanced Instrumentations, Inc.
Obstetrics & Gynecology · 195d
Cleared Nov 19, 2014
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
K141263 · JDR
Biomet Manufacturing Corp
Orthopedic · 188d
Cleared Nov 19, 2014
VARIA-NCI
K141462 · IYN
Neurochaos Solutions, Inc.
Radiology · 169d
Cleared Nov 19, 2014
AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
K141640 · MEG
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 153d
Cleared Nov 19, 2014
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K141755 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 142d
Cleared Nov 19, 2014
ZOLL X SERIES
K141774 · MKJ
ZOLL Medical Corporation
Cardiovascular · 140d
Cleared Nov 19, 2014
ENDO-MARYLAND DISSECTOR
K141794 · KGE
Ovesco Endoscopy AG
Gastroenterology & Urology · 140d