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

Filters: Cleared only ×
175,820 results
30385–30408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2016
Cloud Smart Thermometer
K160306 · FLL
Guangzhou Bosma Technology Co, Ltd.
General Hospital · 313d
Cleared Dec 13, 2016
Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor...
K160335 · DRF
St Jude Medical
Cardiovascular · 309d
Cleared Dec 13, 2016
Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
K160941 · LIT
Brosmed Medical Co., Ltd.
Cardiovascular · 253d
Cleared Dec 13, 2016
Matrix Pre-Treatment Controller
K161844 · FIP
Better Water, LLC
Gastroenterology & Urology · 161d
Cleared Dec 13, 2016
HPM-6000U
K162010 · KPI
BTL Industries, Inc.
Gastroenterology & Urology · 146d
Cleared Dec 13, 2016
MediGuide Technology System
K162643 · DQK
St Jude Medical
Cardiovascular · 82d
Cleared Dec 13, 2016
Carestream DRX-Evolution
K163203 · KPR
Carestream Health, Inc.
Radiology · 28d
Cleared Dec 12, 2016
neoBLUE compact LED Phototherapy System
K160745 · LBI
Natus Medical Incorporated
General Hospital · 269d
Cleared Dec 12, 2016
ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal...
K160969 · GDW
Shinemed, LLC
General & Plastic Surgery · 250d
Cleared Dec 12, 2016
Photon, Photon Plus
K162114 · GEX
Zolar Technology & Mfg Co., Inc.
General & Plastic Surgery · 136d
Cleared Dec 12, 2016
COUGAR® LS Lateral Cage System and COUGAR® System
K162327 · MAX
Medos International SARL
Orthopedic · 115d
Cleared Dec 12, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K162420 · JPA
Siemens Healthcare Diagnostics...
Hematology · 104d
Cleared Dec 12, 2016
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
K162442 · FYA
Gri Medical & Electrical Technology...
General Hospital · 103d
Cleared Dec 12, 2016
Varian High Energy Linear Accelerator
K162476 · IYE
Varian Medical Systems, Inc.
Radiology · 97d
Cleared Dec 12, 2016
U-Blade Veress Needle
K162648 · HIF
Tianjin Uwell Medical Device...
Obstetrics & Gynecology · 81d
Cleared Dec 12, 2016
UC-5000 Mobile X-Ray
K163063 · IZL
Source-Ray, Inc.
Radiology · 40d
Cleared Dec 12, 2016
InMode RF System
K163190 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 28d
Cleared Dec 12, 2016
PK AIM
K163373 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 11d
Cleared CT Dec 10, 2016
STA® - Liatest® D-Di
K162227 · DAP
Diagnostica-Stago
Hematology · 124d
Cleared Dec 09, 2016
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System
K160487 · OMP
Kci USA, Inc.
General & Plastic Surgery · 291d
Cleared Dec 09, 2016
Vanguard Dental Unit
K161734 · EIA
Ritter Concept GmbH
Dental · 169d
Cleared Dec 09, 2016
HYPERION X5
K161900 · OAS
Cefla S.C.
Radiology · 151d
Cleared Dec 09, 2016
Slit Lamp SL-D301
K161972 · HJO
Topcon Corporation
Ophthalmic · 144d
Cleared Dec 09, 2016
Arc EndoCuff and Arc EndoCuff Vision
K162205 · FED
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 126d