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
26137–26160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 2018
VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set
K173757 · FMI
Greiner Bio-One Na, Inc.
General Hospital · 129d
Cleared Apr 19, 2018
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
K180007 · LIT
Creagh Medical, Ltd.
Cardiovascular · 107d
Cleared CT Apr 19, 2018
Embozene Color-Advanced Microspheres
K180102 · NOY
Boston Scientific
Gastroenterology & Urology · 93d
Cleared Apr 19, 2018
syngo.MR Applications
K180336 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 71d
Cleared Apr 19, 2018
Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite...
K180576 · LEJ
Lpi, Inc.
General & Plastic Surgery · 45d
Cleared Apr 19, 2018
CoaguChek XS Plus System
K180684 · GJS
Roche Diagnostics
Hematology · 35d
Cleared Apr 19, 2018
CoaguChek XS Pro System
K180693 · GJS
Roche Diagnostics
Hematology · 34d
Cleared Apr 19, 2018
Ultramatrix EUS Balloon
K180731 · ODG
United States Endoscopy Group, Inc....
Gastroenterology & Urology · 30d
Cleared Apr 19, 2018
Medtronic Model 53401 External Pulse Generator (EPG)
K180873 · DTE
Medtronic, Inc.
Cardiovascular · 16d
Cleared Apr 18, 2018
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K172880 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 209d
Cleared Apr 18, 2018
HALF DOME Posterior Lumbar Interbody System
K172947 · MAX
Astura Medical
Orthopedic · 204d
Cleared Apr 18, 2018
ENZA-A Titanium ALIF
K173432 · OVD
Camber Spine Technologies
Orthopedic · 167d
Cleared Apr 18, 2018
Stryker Universal Select Sterilization Tray System
K173615 · KCT
Paragon Medical
General Hospital · 147d
Cleared Apr 18, 2018
Wingman 35 Crossing Catheter
K173661 · DQY
Reflow Medical, Inc.
Cardiovascular · 140d
Cleared Apr 18, 2018
OVOMotion Shoulder Arthroplasty System
K173964 · HSD
Arthrosurface, Inc.
Orthopedic · 110d
Cleared Apr 18, 2018
RAILWAY Sheathless Access System
K180081 · DYB
Cordis Corporation
Cardiovascular · 97d
Cleared Apr 18, 2018
Genistrong
K180836 · GCJ
Genicon, Inc.
General & Plastic Surgery · 19d
Cleared Apr 18, 2018
VERTEX™ Reconstruction System
K180851 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Apr 17, 2018
Fusion OMNI Sphincterotome
K172288 · KNS
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 260d
Cleared Apr 17, 2018
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm,...
K172610 · GEI
Olympus Medical Systems Corp.
General & Plastic Surgery · 229d
Cleared Apr 17, 2018
WR19 System
K172735 · GWQ
Zeto, Inc.
Neurology · 218d
Cleared Apr 17, 2018
DiLumen C2
K173317 · FDF
Lumendi, LLC
Gastroenterology & Urology · 180d
Cleared Apr 17, 2018
Penumbra Coil 400, Ruby Coil System, POD System
K173614 · HCG
Penumbra, Inc.
Neurology · 146d
Cleared Apr 17, 2018
NM/CT 850, NM/CT 860
K173816 · KPS
Ge Healthcare
Radiology · 123d