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
29785–29808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2016
Cryotec
K162051 · MQK
Reprolife, Inc.
Obstetrics & Gynecology · 142d
Cleared Dec 14, 2016
ENNOVATE Spinal System
K162134 · NKB
Aesculap Implant Systems, LLC
Orthopedic · 135d
Cleared Dec 14, 2016
Westmed Gas Sampling Cannula with O2 delivery
K162343 · CCK
Westmed, Inc.
Anesthesiology · 114d
Cleared Dec 14, 2016
SOVEREIGN® Spinal System
K162680 · OVD
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 79d
Cleared Dec 14, 2016
PowerMidline Catheter
K162900 · PND
C.R. Bard, Inc.
General Hospital · 58d
Cleared Dec 14, 2016
XLTEK EMU40EX EEG Headbox
K163163 · GWQ
Natus Medical Incorporated Dba...
Neurology · 34d
Cleared Dec 14, 2016
Emerge PTCA Dilatation Catheter
K163174 · LOX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Dec 14, 2016
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail...
K163200 · LOX
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Dec 13, 2016
EnSite Precision Cardiac Mapping System v2.0
K160210 · DQK
St Jude Medical
Cardiovascular · 320d
Cleared Dec 13, 2016
AutoMark Module
K160218 · DQK
St Jude Medical
Cardiovascular · 319d
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