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
24817–24840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2018
uMR 780
K181370 · LNH
Shanghai United Imaging Healthcare...
Radiology · 133d
Cleared Oct 03, 2018
uMR 790
K181371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 133d
Cleared Oct 03, 2018
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose...
K181527 · NBW
ACON Laboratories, Inc.
Chemistry · 114d
Cleared Oct 03, 2018
Outlet Sacroiliac Joint Fusion System
K181881 · OUR
Sij Surgical
Orthopedic · 82d
Cleared Oct 03, 2018
FIREFLY® Midline Navigation Guide
K181883 · PQC
Mighty Oak Medical, Inc.
Orthopedic · 82d
Cleared Oct 03, 2018
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes,...
K181903 · JAQ
Varian Medical Systems, Inc.
Radiology · 79d
Cleared Oct 03, 2018
Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation...
K182050 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 64d
Cleared Oct 03, 2018
Vinyl Patient Examination Gloves
K182115 · LYZ
Pingan Medical Products Co., Ltd.
General Hospital · 58d
Cleared Oct 03, 2018
2MP Color LCD Monitor CL-R211
K182539 · PGY
Jvckenwood Corporation
Radiology · 19d
Cleared Oct 02, 2018
NOxBOXi Nitric Oxide Delivery System
K171696 · MRN
Praxair Distribution, Inc.
Anesthesiology · 482d
Cleared Oct 02, 2018
KLOCKNER SURGICAL BOX
K173642 · KCT
SOADCO, S.L.
General Hospital · 312d
Cleared Oct 02, 2018
Infrared Ear Thermometer
K181081 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 161d
Cleared Oct 02, 2018
Deka Smartxide2 Trio
K181867 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 82d
Cleared Oct 02, 2018
Voyant System
K181885 · HRX
Viseon, Inc.
General & Plastic Surgery · 81d
Cleared Oct 02, 2018
FUJIFILM Duodenoscope Model
K182051 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 63d
Cleared Oct 01, 2018
MPS2 Myocardial Protection System Console
K173716 · DTR
Quest Medical, Inc.
Cardiovascular · 300d
Cleared Oct 01, 2018
AMSure Hydrophilic Intermittent Catheter
K181445 · EZD
Amsino International, Inc.
Gastroenterology & Urology · 122d
Cleared Oct 01, 2018
StrataMR guider tool
K181622 · JXG
Medtronic Neurosurgery
Neurology · 103d
Cleared Sep 28, 2018
Kawasumi Laboratories Blood Drawing Kit (BDK) System
K172957 · KSB
Kawasumi Laboratories, Inc.
General Hospital · 367d
Cleared Sep 28, 2018
FibriCheck
K173872 · DXH
Qompium NV
Cardiovascular · 282d
Cleared Sep 28, 2018
BioCode Gastrointestinal Pathogen Panel (GPP)
K180041 · PCH
Applied BioCode, Inc.
Microbiology · 266d
Cleared Sep 28, 2018
ORISE Gel
K180068 · PLL
Boston Scientific
Gastroenterology & Urology · 262d
Cleared Sep 28, 2018
Seidmon Antegrade AQ Stent Set
K180216 · FAD
Cook Incorporated
Gastroenterology & Urology · 246d
Cleared Sep 28, 2018
Orthocaps Twinaligner
K180241 · NXC
Ortho Caps GmbH
Dental · 242d