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
529–552 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 12, 2018
Magnesium
K181748 · JGJ
Abbott Laboratories
Chemistry · 72d
Cleared Sep 04, 2018
NeoBase 2 Non-derivatized MSMS Kit
K173568 · NQL
Wallac Oy, Subsidiary of Perkinelmer,...
Chemistry · 288d
Cleared Aug 31, 2018
CareSens S Fit Blood Glucose Monitoring System
K180866 · NBW
I-Sens, Inc.
Chemistry · 151d
Cleared Aug 24, 2018
EasyMax BT Self-Monitoring Blood Glucose System
K182057 · NBW
Eps Bio Technology Corp.
Chemistry · 24d
Cleared Aug 23, 2018
Stat Profile Prime Plus Analyzer System
K180186 · GGZ
Nova Biomedical Corporation
Chemistry · 212d
Cleared Aug 21, 2018
Confidence Blood Glucose Monitoring System
K173658 · NBW
Applied Biomedical, LLC
Chemistry · 265d
Cleared Aug 17, 2018
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose...
K173638 · NBW
Bionime Corporation
Chemistry · 266d
Cleared Aug 15, 2018
Stat Profile Prime Plus Analyzer System
K180428 · JGS
Nova Biomedical Corporation
Chemistry · 180d
Cleared Aug 09, 2018
FORA GTel Blood Glucose Monitoring System
K173505 · NBW
Foracare, Inc.
Chemistry · 269d
Cleared Jul 20, 2018
Free Testosterone AccuBind ELISA Test System
K181017 · CDZ
Monobind, Inc.
Chemistry · 101d
Cleared Jul 19, 2018
Atellica IM High-Sensitivity Troponin I (TNIH)
K171566 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 415d
Cleared Jul 18, 2018
NeoLSD MSMS kit
K173829 · PQW
Wallac Oy, A Subsidiary of Perkinelmer
Chemistry · 212d
Cleared Jul 18, 2018
DIP/U.S. Urine Analysis Test System
K173327 · JIL
Healthy.Io, Ltd.
Chemistry · 271d
Cleared Jul 17, 2018
Stat Profile Prime Plus Analyzer System
K173797 · CHL
Nova Biomedical Corporation
Chemistry · 215d
Cleared Jul 13, 2018
Dimension Hemoglobin A1c Assay
K173909 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 203d
Cleared Jul 12, 2018
StatStrip Glucose Hospital Meter System
K181043 · PZI
Nova Biomedical Corporation
Chemistry · 84d
Cleared Jul 12, 2018
ActiveCare TD-4121 Blood Glucose Monitoring System
K173511 · NBW
Taidoc Technology Corporation
Chemistry · 241d
Cleared Jul 12, 2018
SEKURE HbA1c Assay
K173206 · PDJ
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 283d
Cleared Jul 12, 2018
ADVIA Centaur High-Sensitivity Troponin I (TNIH)
K171274 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 437d
Cleared Jul 10, 2018
Synermed ISE Reagents
K181201 · JGS
Infrared Laboratory Systems, LLC (Dba...
Chemistry · 64d
Cleared Jun 22, 2018
BioPlex 2200 25-OH Vitamin D Kit
K180577 · MRG
Bio-Rad Laboratories
Chemistry · 109d
Cleared Jun 19, 2018
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose...
K173139 · NBW
Bionime Corporation
Chemistry · 263d
Cleared Jun 14, 2018
POGO Automatic Blood Glucose Monitoring System
K181316 · NBW
Intuity Medical, Inc.
Chemistry · 27d
Cleared Jun 14, 2018
Access hsTnl
K172787 · MMI
Beckman Coulter, Inc.
Chemistry · 272d