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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
337–360 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 05, 2021
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood...
K201394 · NBW
I-Sens, Inc.
Chemistry · 496d
Cleared Oct 04, 2021
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
K201312 · NBC
Ortho-Clinical Diagnostics
Chemistry · 504d
Cleared Sep 28, 2021
Advisor Pro Platform
K210561 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 215d
Cleared Sep 21, 2021
Elecsys Troponin T Gen 5
K201441 · MMI
Roche Diagnostics
Chemistry · 477d
Cleared Sep 21, 2021
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine,...
K200898 · CIX
Medicon Hellas S.A
Chemistry · 536d
Cleared Sep 15, 2021
GlucoSure HT Plus Blood Glucose Monitoring System
K202885 · NBW
Apex BioTechnology Corp.
Chemistry · 352d
Cleared Sep 08, 2021
BlueStar Rx
K203434 · NDC
Welldoc, Inc.
Chemistry · 289d
Cleared Sep 01, 2021
Elecsys Vitamin D total III
K210901 · MRG
Roche Diagnostics
Chemistry · 159d
Cleared Sep 01, 2021
EASYMAX Tag Self-Monitoring Blood Glucose System
K201258 · NBW
Eps Bio Technology Corp.
Chemistry · 478d
Cleared Aug 20, 2021
GEM Premier 5000
K203790 · CHL
Instrumentation Laboratory CO
Chemistry · 235d
Not Cleared Aug 20, 2021
ADVIA Centaur Enhanced Liver Fibrosis (ELF)
DEN190056 · QQB
Siemens Healthcare Diagnostics, Inc.
Chemistry · 603d
Cleared Aug 18, 2021
Elecsys HCG STAT
K203227 · DHA
Roche Diagnostics
Chemistry · 289d
Cleared Aug 17, 2021
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K203089 · QDK
Dexcom, Inc.
Chemistry · 308d
Cleared Aug 13, 2021
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
K211575 · LZG
Insulet Corporation
Chemistry · 84d
Cleared Aug 13, 2021
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K210958 · CGA
Abbott Point of Care, Inc.
Chemistry · 135d
Cleared Aug 13, 2021
Clearblue® Early Digital Pregnancy Test
K200913 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 494d
Cleared Aug 11, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System
K211102 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 120d
Cleared Aug 11, 2021
CONTOUR® NEXT ONE Blood Glucose Monitoring System
K210687 · NBW
Ascensia Diabetes Care
Chemistry · 156d
Cleared Aug 06, 2021
Diazyme PLAC® Test for Lp-PLA2 Activity
K203136 · NOE
Diazyme Laboratories, Inc.
Chemistry · 290d
Cleared Aug 05, 2021
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
K200904 · PDJ
Tosoh Bioscience, Inc.
Chemistry · 486d
Cleared Aug 04, 2021
Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine...
K203246 · LCX
Atlas Link Technology Co., Ltd.
Chemistry · 273d
Cleared Aug 02, 2021
OPTI® B-Lac Cassette
K200986 · CHL
Opti Medical Systems, Inc.
Chemistry · 474d
Cleared Jul 30, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K201761 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 396d
Cleared Jul 16, 2021
Medtronic Extended infusion set
K210544 · FPA
Unomedical A/S
Chemistry · 142d