Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
30865–30888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 2016
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K162597 · LPN
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Oct 18, 2016
EasyMap MAP Catheter
K151139 · DRF
Medfact Engineering GmbH
Cardiovascular · 538d
Cleared Oct 18, 2016
Rampart D Lumbar Interbody Fusion Device
K160074 · MAX
Spineology, Inc.
Orthopedic · 278d
Cleared Oct 18, 2016
VITROS® Automation Solutions
K160495 · KLI
Ortho-Clinical Diagnostics, Inc.
Chemistry · 239d
Cleared Oct 18, 2016
NOBLUS™ Ultrasound Diagnostic System
K160559 · IYN
Hitachi Medical Corporation
Radiology · 232d
Cleared Oct 18, 2016
ENROUTE 0.014 Guidewire
K160643 · DQX
Lake Region Medical
Cardiovascular · 225d
Cleared Oct 18, 2016
Premier Sealant
K161580 · EBC
Premier Dental Company Products
Dental · 132d
Cleared Oct 18, 2016
ClearLumen II Thrombectomy System
K161786 · QEZ
Walk Vascular, LLC
Cardiovascular · 111d
Cleared Oct 18, 2016
Neuromonitoring Kit
K161893 · PDQ
SI-BONE, Inc.
Neurology · 99d
Cleared Oct 18, 2016
IntelliSpace Portal Platform
K162025 · LLZ
Philips Medical Systems Nederlands B.V.
Radiology · 88d
Cleared Oct 18, 2016
16ch T/R Knee Coil
K162029 · MOS
Quality Electrodynamics, LLC
Radiology · 88d
Cleared Oct 18, 2016
Medtronic Temporary External Pacemaker 53401
K162054 · DTE
Medtronic, Inc.
Cardiovascular · 85d
Cleared Oct 18, 2016
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
K162326 · MCW
Avinger, Inc.
Cardiovascular · 60d
Cleared Oct 18, 2016
VersaOne Bladeless Trocar
K162584 · GCJ
Covidien
General & Plastic Surgery · 32d
Cleared Oct 18, 2016
NovoPen Echo
K162602 · FMF
Novo Nordisk, Inc.
General Hospital · 29d
Cleared Oct 18, 2016
Fujifilm Endoscope Models EC-600HL and EC-600LS
K162622 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 17, 2016
OSSTEM Implant System
K161604 · DZE
Osstem Implant Co., Ltd.
Dental · 129d
Cleared Oct 17, 2016
bk2300
K161960 · IYN
Bk Medical Aps
Radiology · 91d
Cleared Oct 17, 2016
Infinix, INFX-8000V, V6.35
K162614 · OWB
Toshibamedical Systems Corporation
Radiology · 28d
Cleared Oct 14, 2016
IH Implant System
K153521 · DZE
Sewonmedix, Inc.
Dental · 311d
Cleared Oct 14, 2016
FREND Testosterone Test System
K153577 · CDZ
Nanoentek USA, Inc.
Chemistry · 304d
Cleared Oct 14, 2016
Fingertip Pulse Oximeter MD300CG11/MD300CG51
K160268 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 255d
Cleared Oct 14, 2016
ANYVIEW-500R Fluoroscopic Mobile X-Ray System
K160279 · OWB
Ecotron Co., Ltd.
Radiology · 255d
Cleared Oct 14, 2016
NovaPACS
K160371 · LLZ
Novarad Corporation
Radiology · 247d