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
481–504 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 19, 2019
Stat Profile Prime ES Comp Plus Analyzer System
K191365 · JGS
Nova Biomedical Corporation
Chemistry · 58d
Cleared CT Jul 18, 2019
DreaMed Advisor Pro
K191370 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 57d
Cleared Jun 28, 2019
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program...
K191450 · QBJ
Dexcom, Inc.
Chemistry · 28d
Cleared Jun 17, 2019
IDS SHBG
K190121 · CDZ
Immunodiagnostic Systems , Ltd.
Chemistry · 143d
Cleared Jun 12, 2019
On Call Express Voice Blood Glucose Monitoring System
K191038 · NBW
ACON Laboratories, Inc.
Chemistry · 55d
Cleared Jun 12, 2019
LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent,...
K172232 · JGS
Ams Diagnostics
Chemistry · 687d
Cleared Jun 07, 2019
VITROS XT Chemistry Products ALB-TP Slides
K191316 · CIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 23d
Cleared Jun 04, 2019
TD-4183 Blood Glucose Monitoring System
K190579 · NBW
Taidoc Technology Corporation
Chemistry · 90d
Cleared Jun 02, 2019
Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose...
K190564 · NBW
Bionime Corporation
Chemistry · 89d
Cleared May 17, 2019
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
K190675 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 63d
Cleared May 15, 2019
VeriClear Digital Early Result Pregnancy Test
K182328 · LCX
True Diagnostics, Inc.
Chemistry · 261d
Cleared May 08, 2019
GlucoLeader Enhance Blood Glucose Monitoring System
K182428 · NBW
Hmd Biomedical, Inc.
Chemistry · 244d
Cleared May 07, 2019
cobas u 601 urinalysis test system
K183432 · JIL
Roche Diagnostics
Chemistry · 147d
Cleared May 03, 2019
NeoLSD MSMS Kit
K190266 · PQW
Perkinelmer, Inc.
Chemistry · 84d
Cleared May 02, 2019
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN...
K182474 · JFJ
Biosystems S.A.
Chemistry · 234d
Cleared Apr 26, 2019
VITROS XT Chemistry Products TBIL-ALKP Slides
K190807 · CIG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Apr 17, 2019
SEKURE Creatine Kinase Assay
K182702 · CGS
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 202d
Cleared Apr 16, 2019
Elecsys TSH
K190773 · JLW
Roche Diagnostics
Chemistry · 21d
Cleared Apr 15, 2019
WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test...
K190705 · LCX
Wholepower Biotech Co., Ltd.
Chemistry · 27d
Cleared Apr 12, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K181915 · LCP
Ixensor Co, Ltd.
Chemistry · 269d
Cleared Apr 10, 2019
GLUCOCARD® W onyx Blood Glucose Monitoring System
K183306 · NBW
Arkray Factory, Inc.
Chemistry · 133d
Cleared Apr 03, 2019
VITROS XT Chemistry Products GLU-Ca Slides
K190520 · CGA
Ortho-Clinical Diagnostics, Inc.
Chemistry · 30d
Cleared Mar 27, 2019
VITROS XT Chemistry Products TRIG-CHOL Slides
K190490 · CHH
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Mar 14, 2019
VITROS XT Chemistry Products UREA-CREA Slides
K190326 · CDN
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d