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
289–312 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 27, 2023
EasyStat 300
K211559 · CHL
Medica Corporation
Chemistry · 617d
Cleared Jan 27, 2023
Tacrolimus Assay Kit
K203833 · MLM
Shanghai Genext Medical Technology...
Chemistry · 758d
Cleared Jan 23, 2023
Tidepool Loop
K203689 · QJI
Tidepool Project
Chemistry · 767d
Cleared Jan 19, 2023
Access 25(OH) Vitamin D Total
K223503 · MRG
Beckman Coulter, Inc.
Chemistry · 58d
Cleared Jan 13, 2023
Access Testosterone
K223405 · CDZ
Beckman Coulter, Inc.
Chemistry · 65d
Cleared Jan 11, 2023
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K223931 · QBJ
Dexcom, Inc.
Chemistry · 12d
Cleared Dec 29, 2022
Total Bilirubin2
K223324 · CIG
Abbott Ireland Diagnostics Division
Chemistry · 59d
Cleared Dec 27, 2022
Access Total ßhCG (5th IS)
K221990 · DHA
Beckman Coulter, Inc.
Chemistry · 174d
Cleared Dec 23, 2022
Access Vitamin B12
K223289 · CDD
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Dec 22, 2022
Lp(a) Ultra
K211058 · DFC
SENTINEL CH. SpA
Chemistry · 622d
Cleared Dec 21, 2022
GlucoSure ADVANCE Link Blood Glucose Monitoring System
K222234 · NBW
Apex BioTechnology Corp.
Chemistry · 148d
Cleared Dec 16, 2022
CardioPhase® hsCRP
K212559 · NQD
Siemens Healthcare Diagnostics...
Chemistry · 490d
Cleared Dec 07, 2022
Dexcom G7 Continuous Glucose Monitoring System
K213919 · QBJ
Dexcom, Inc.
Chemistry · 357d
Cleared Nov 30, 2022
MissLan™ Digital Pregnancy Rapid Test
K222305 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 121d
Cleared Nov 18, 2022
CONTOUR® NEXT GEN Blood Glucose Monitoring System
K223293 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 23d
Cleared Nov 10, 2022
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · JLW
Beckman Coulter, Inc.
Chemistry · 196d
Cleared Nov 04, 2022
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring...
K220421 · NBW
Apex BioTechnology Corp.
Chemistry · 263d
Cleared Oct 27, 2022
ORAcollect®•Dx
K212745 · OYJ
DNA Genotek, Inc.
Chemistry · 423d
Cleared Oct 26, 2022
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
K221885 · QDJ
23AndMe, Inc.
Chemistry · 119d
Cleared Oct 18, 2022
Nova Primary Glucose Analyzer System
K203549 · CGA
Nova Biomedical Corporation
Chemistry · 683d
Cleared Oct 07, 2022
SuperCheck Pro Blood Glucose Monitoring System
K213061 · NBW
Ok Biotech Co., Ltd.
Chemistry · 380d
Cleared Sep 21, 2022
Clearblue ® Early Pregnancy Test
K213379 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 343d
Cleared Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2,...
K220134 · CFR
Roche Diagnostics
Chemistry · 241d
Cleared Aug 29, 2022
GlucoLeader Enhance 2 Blood Glucose Monitoring System
K212248 · NBW
Hmd Biomedical, Inc.
Chemistry · 406d