FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
26593–26616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2018
CorPath GRX System
K173806 · DXX
Corindus, Inc.
Cardiovascular · 76d
Cleared Mar 01, 2018
STARband, STARlight, St. Louis Band
K180109 · OAN
Orthomerica Products, Inc.
Neurology · 44d
Cleared Feb 28, 2018
Wireless Probe Type Ultrasound Scanner (Model:UProbe-C
K172750 · IYO
Guangzhou Sonostar Technologies Co.,...
Radiology · 169d
Cleared Feb 28, 2018
ECG Cable/Leadwires
K172797 · DSA
Shenzhen Coreray Technology, Ltd.
Cardiovascular · 166d
Cleared Feb 28, 2018
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein...
K172868 · DCN
The Binding Site Group , Ltd.
Immunology · 161d
Cleared Feb 28, 2018
CereMetrix Silver
K173145 · LLZ
Ceremetrix Corp
Radiology · 152d
Cleared Feb 28, 2018
S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050,...
K173186 · GXY
Everyway Medical Instruments Co.,Ltd
Neurology · 149d
Cleared Feb 28, 2018
MC 300* Nebulizer
K173367 · CAF
Trudell Medical International
Anesthesiology · 125d
Cleared Feb 28, 2018
VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable...
K173633 · FRC
STERIS Corporation
General Hospital · 96d
Cleared Feb 28, 2018
Diode Laser Cap
K173678 · OAP
Cosmo Far East Technology Limited
General & Plastic Surgery · 90d
Cleared Feb 28, 2018
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
K173691 · LSR
Quidel Corporation
Microbiology · 89d
Cleared CT Feb 28, 2018
P200TE
K173707 · OBO
Optos Plc.
Ophthalmic · 86d
Cleared Feb 28, 2018
REVIAN RED
K173729 · OAP
Photonmd, Inc.
General & Plastic Surgery · 84d
Cleared Feb 28, 2018
TrackX
K173736 · OWB
Track X Technology, LLC
Radiology · 84d
Cleared Feb 28, 2018
ALOKA ARIETTA 850
K173739 · IYN
Hitachi Healthcare Americas Corporation
Radiology · 83d
Cleared Feb 28, 2018
iovera system
K173763 · GXH
Myoscience, Inc.
Neurology · 79d
Cleared Feb 28, 2018
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
K173817 · JWY
Liofilchem S. R. L.
Microbiology · 75d
Cleared Feb 28, 2018
HeRO Symphony, HeRO ES, HeRO solo/duet
K180242 · DPS
Medical Predictive Science Corporation
Cardiovascular · 30d
Cleared Feb 28, 2018
EnsoETM
K180244 · PLA
Advanced Cooling Therapy, Inc. D/B/A...
Cardiovascular · 30d
Cleared Feb 28, 2018
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
K180255 · PTH
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 29d
Cleared Feb 27, 2018
ACE Hemoglobin A1c (HbA1c) Reagent
K170623 · LCP
Alfa Wassermann Diagnostic...
Chemistry · 363d
Cleared Feb 27, 2018
SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
K171476 · JGS
Awareness Technology, Inc.
Chemistry · 284d
Cleared Feb 27, 2018
NeuroNav System, NeuroSmart System
K172042 · GZL
Alpha Omega Engineering , Ltd.
Neurology · 236d
Cleared Feb 27, 2018
Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex...
K172044 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 236d