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
26473–26496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Mar 14, 2018
Specular Microscope CEM-530
K173980 · NQE
Nidek Co., Ltd.
Ophthalmic · 75d
Cleared Mar 14, 2018
Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
K180104 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 57d
Cleared Mar 14, 2018
Natus NeuroWorks
K180421 · OMB
Natus Medical Incorporated Dba...
Neurology · 26d
Cleared Mar 14, 2018
Advincula Delineator Uterine Manipulator
K180429 · HEW
CooperSurgical, Inc.
Obstetrics & Gynecology · 26d
Cleared Mar 13, 2018
Biodesign Diaphragmatic Hernia Graft
K171817 · FTM
Cook Biotech Incorporated
General & Plastic Surgery · 267d
Cleared Mar 13, 2018
Olympus Small Intestinal Capsule Endoscope System
K173459 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 126d
Cleared Mar 13, 2018
STERIZONE VP4 Sterilizer
K173694 · PJJ
Tso3, Inc.
General Hospital · 102d
Cleared Mar 13, 2018
Custom Clear Aligner System
K173785 · NXC
Derby Dental Laboratory
Dental · 90d
Cleared Mar 13, 2018
EliA PR3s Immunoassay
K173792 · MOB
Phadia AB
Immunology · 89d
Cleared Mar 13, 2018
ThinkQA
K180106 · IYE
Dosisoft
Radiology · 56d
Cleared Mar 13, 2018
Voluson S8/ Voluson S10/ Voluson S10 Expert
K180374 · IYN
Ge Healthcare
Radiology · 29d
Cleared Mar 12, 2018
Preview Digital Pregnancy Test
K173229 · LCX
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 159d
Cleared Mar 12, 2018
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
K173583 · OQI
Exactech, Inc.
Orthopedic · 112d
Cleared Mar 12, 2018
RocaJJ Soft Stents
K173734 · FAD
Promepla Sam
Gastroenterology & Urology · 96d
Cleared Mar 12, 2018
REXMONO, PDREX
K173779 · GAM
Sm Eng Co., Ltd.
General & Plastic Surgery · 90d
Cleared Mar 12, 2018
SICAT Endo
K180262 · LLZ
Sicat GmbH & Co. KG
Radiology · 41d
Cleared Mar 12, 2018
Corvocet Biopsy System
K180450 · KNW
Merit Medical Systems, Inc.
Gastroenterology & Urology · 20d
Cleared Mar 10, 2018
Acclarent ENT Navigation System
K173628 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 106d
Cleared Mar 09, 2018
Wrist Type Blood Pressure Monitor
K162616 · DXN
Xuzhou Yongkang Electronic Science...
Cardiovascular · 535d
Cleared Mar 09, 2018
Fixed Core Wire Guides
K171764 · DQX
Cook Incorporated
Cardiovascular · 268d
Cleared Mar 09, 2018
Transjugular Liver Access Sets
K171820 · DYB
Cook Incorporated
Cardiovascular · 263d
Cleared Mar 09, 2018
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets,...
K172057 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 246d
Cleared Mar 09, 2018
Positional Sleep Assessment System (PoSAS) software
K172799 · MNR
Advanced Brain Monitoring
Anesthesiology · 172d
Cleared Mar 09, 2018
Powder-free Clear Vinyl Patient Examination Gloves
K173078 · LYZ
Yongsheng Medical Products Co., Ltd.
General Hospital · 161d