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
145–168 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 03, 2024
Emily's Care Nourish Test System (Model 1)
K234088 · QEI
Lactation Lab, Inc.
Chemistry · 133d
Not Cleared Apr 29, 2024
Eversense AP CGM System
DEN230052 · SBA
Senseonics, Incorporated
Chemistry · 264d
Cleared Apr 26, 2024
UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA...
K232317 · JIO
Urit Medical Electronic Co., Ltd.
Chemistry · 267d
Cleared Apr 26, 2024
cobas pulse blood glucose monitoring system
K220272 · PZI
Roche Diagnostics
Chemistry · 816d
Cleared Apr 23, 2024
FreeStyle Libre 3 Continuous Glucose Monitoring System
K233537 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 172d
Cleared Apr 15, 2024
Access Ostase
K232904 · CIN
Beckman Coulter
Chemistry · 210d
Cleared Apr 12, 2024
HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx,...
K233624 · LCX
Hangzhou Aichek Medical Technology...
Chemistry · 151d
Cleared Apr 12, 2024
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay...
K232587 · MRG
Shenzhen New Industries Biomedical...
Chemistry · 231d
Cleared Apr 12, 2024
Access NT-proBNP
K232164 · NBC
Beckman Coulter, Inc.
Chemistry · 266d
Cleared Apr 05, 2024
ACESO Early Pregnancy Test
K234152 · LCX
Aceso Laboratories, Inc.
Chemistry · 98d
Cleared Apr 04, 2024
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
K233050 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 192d
Cleared Mar 22, 2024
Elecsys PTH , Elecsys PTH STAT
K231927 · CEW
Roche Diagnostics
Chemistry · 266d
Cleared Mar 21, 2024
Tandem Mobi insulin pump with interoperable technology
K240309 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 48d
Cleared Mar 20, 2024
PATHFAST®hs-cTnI-II
K231974 · MMI
Phc Corporation
Chemistry · 261d
Cleared Mar 13, 2024
DEKA Loop
K234055 · QJI
Deka Research and Development
Chemistry · 82d
Cleared Mar 13, 2024
DEKA ACE Pump System
K233952 · QFG
Deka Research and Development
Chemistry · 89d
Cleared Mar 06, 2024
Access Free T4
K240273 · CEC
Beckman Coulter, Inc.
Chemistry · 35d
Cleared Mar 05, 2024
Stelo Glucose Biosensor System
K234070 · SAF
Dexcom, Inc.
Chemistry · 74d
Cleared Mar 01, 2024
Access Intact PTH
K232791 · CEW
Beckman Coulter, Inc.
Chemistry · 172d
Cleared Feb 23, 2024
StatStrip Glucose Hospital Meter System
K232075 · PZI
Nova Biomedical Corporation
Chemistry · 226d
Cleared Feb 23, 2024
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K231679 · NBW
Ascensia Diabetes Care
Chemistry · 259d
Cleared Feb 22, 2024
Vivatmo pro
K233775 · MXA
Bosch Healthcare Solutions GmbH
Chemistry · 90d
Cleared Feb 16, 2024
Access CK-MB
K234005 · JHX
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Feb 08, 2024
Access SHBG
K233480 · CDZ
Beckman Coulter, Inc.
Chemistry · 105d