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
28609–28632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2017
RT300 FES cycle ergometer
K162470 · GZI
Restorative Therapies, Inc.
Neurology · 308d
Cleared Jul 11, 2017
Kitazato OPU Needles
K162881 · MQE
Kitazato Corporation
Obstetrics & Gynecology · 270d
Cleared Jul 11, 2017
Needle's Eye Snare Retrieval Set - 54cm
K163353 · DXE
Cook Incorporated
Cardiovascular · 223d
Cleared Jul 11, 2017
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
K163406 · CHH
ACON Laboratories, Inc.
Chemistry · 218d
Cleared Jul 11, 2017
EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT...
K170503 · MAX
Eit Emerging Implant Technologies GmbH
Orthopedic · 140d
Cleared Jul 11, 2017
Devon 24
K170814 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 116d
Cleared Jul 11, 2017
P60 Series Digital Color Doppler Ultrasound System
K171000 · IYN
Sonoscape Medical Corp.
Radiology · 99d
Cleared Jul 11, 2017
AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
K171105 · IYN
Supersonic Imagine
Radiology · 89d
Cleared Jul 11, 2017
Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and...
K171133 · IYE
Qfix
Radiology · 85d
Cleared Jul 11, 2017
O2Vent W
K171316 · LRK
Oventus Manufacturing Pty, Ltd.
Dental · 68d
Cleared Jul 11, 2017
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems...
K171401 · CIG
Elitechgroup
Chemistry · 60d
Cleared Jul 11, 2017
OrthAlign Plus System
K171780 · OLO
Orthalign, Inc.
Orthopedic · 26d
Cleared Jul 11, 2017
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
K171908 · SEL
3M Company
General & Plastic Surgery · 15d
Cleared Jul 10, 2017
Biodesign Parastomal Hernia Repair Graft
K162934 · FTM
Cook Biotech Incorporated
General & Plastic Surgery · 263d
Cleared Jul 10, 2017
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile,...
K170397 · LZA
Kossan International Sdn Bhd
General Hospital · 151d
Cleared Jul 10, 2017
Mini Needle
K170768 · FMI
Ocuject, LLC
General Hospital · 118d
Cleared Jul 10, 2017
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV...
K171034 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 95d
Cleared Jul 10, 2017
TRI-COMBO PARASITE SCREEN
K171078 · MHJ
Techlab, Inc.
Microbiology · 90d
Cleared Jul 10, 2017
XiniWave II Model ECS322P
K171092 · NGX
International Trade Group, Inc.
Physical Medicine · 89d
Cleared Jul 07, 2017
Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
K160337 · QPC
Bam Corporation Limited
General Hospital · 515d
Cleared Jul 07, 2017
Everyway Incontinence Stimulation System
K161349 · KPI
Everyway Medical Instrument Co., Ltd.
Gastroenterology & Urology · 417d
Cleared Jul 07, 2017
Karl Storz UROMAT E.A.S.I.
K162992 · LJH
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 253d
Cleared Jul 07, 2017
DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
K163035 · LZA
Elm Tree Medical, Inc.
General Hospital · 249d
Cleared Jul 07, 2017
M3290B Philips IntelliVue Information Center iX
K163584 · MHX
Philips Medical Systems
Cardiovascular · 199d