Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
169–192 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 CT 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 CT 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
Cleared Feb 05, 2024
FaStep™ Pregnancy Rapid Test Strip
K233174 · LCX
Assure Tech. (Hangzhou) Co, Ltd.
Chemistry · 130d