FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
31009–31032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2016
Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved...
K161137 · GDW
Cardica, Inc.
General & Plastic Surgery · 89d
Cleared Jul 20, 2016
St. Louis Band
K161138 · OAN
Orthomerica Products, Inc.
Neurology · 89d
Cleared Jul 20, 2016
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
K161227 · LON
bioMerieux, Inc.
Microbiology · 79d
Cleared Jul 19, 2016
ABPM 7100, Hypertension Management Software
K153557 · DXN
I.E.M. GmbH
Cardiovascular · 218d
Cleared Jul 19, 2016
INTRAFIX(TM) Advance Tibial Fastener System
K160804 · MAI
Medos International SARL
Orthopedic · 118d
Cleared Jul 19, 2016
DePuy Actis DuoFix Hip Prosthesis
K160907 · MEH
Depuy(Ireland)
Orthopedic · 109d
Cleared Jul 19, 2016
Origin Coxa Vara Hip Stem
K161155 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 85d
Cleared Jul 19, 2016
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
K161359 · IYN
Esaote, S.P.A.
Radiology · 64d
Cleared Jul 19, 2016
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K161443 · PHL
Ekso Bionics, Inc.
Neurology · 55d
Cleared Jul 19, 2016
EnCor MRI Introducer Set, EnCor Probe Introducer
K161805 · KNW
Senorx, Inc.
Gastroenterology & Urology · 18d
Cleared Jul 18, 2016
RI Witness Embryology Heated Plate
K160504 · MQG
Research Instruments Limited
Obstetrics & Gynecology · 145d
Cleared Jul 15, 2016
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid...
K151978 · CHL
Edan Instruments, Inc.
Chemistry · 364d
Cleared Jul 15, 2016
FDR Visionary Suite
K152294 · KPR
Shimadzu Corporation
Radiology · 337d
Cleared Jul 15, 2016
Belvedere™ Lateral Plating System
K153097 · KWQ
Neurostructures, Inc.
Orthopedic · 263d
Cleared Jul 15, 2016
Juliet® Ti
K153621 · MAX
Spineart
Orthopedic · 210d
Cleared Jul 15, 2016
Steth IO
K160016 · DQD
Stratoscientific, Inc.
Cardiovascular · 192d
Cleared Jul 15, 2016
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
K160271 · MSH
San-M Package Co., Ltd.
General Hospital · 164d
Cleared Jul 15, 2016
Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
K160308 · FLL
Fudakang Industrial Co., Ltd.
General Hospital · 162d
Cleared Jul 15, 2016
CAD/CAMouflage Milling Bock
K160425 · EBF
Prismatik Dentalcraft, Inc.
Dental · 150d
Cleared Jul 15, 2016
Keos Lumbar IBFD
K160631 · MAX
Keos
Orthopedic · 130d
Cleared Jul 15, 2016
myPatch-s
K160704 · DSH
Dms-Service, LLC
Cardiovascular · 123d
Cleared Jul 15, 2016
TransContinental® M Spacers and InterContinental® Plate-Spacers
K161223 · OVD
Globus Medical, Inc.
Orthopedic · 77d
Cleared Jul 15, 2016
NuVasive® VersaTie System
K161265 · OWI
Nu Vasive, Incorporated
Orthopedic · 71d
Cleared Jul 15, 2016
Ascential IBD PEEKc Spacer
K161407 · ODP
Stryker Spine
Orthopedic · 56d