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

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175,820 results
31777–31800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 2016
Unifine Pentips/ Unifine Pentips Plus
K152339 · FMI
Owen Mumford, Ltd.
General Hospital · 310d
Cleared Jun 24, 2016
Resmon PRO FULL
K152585 · PNV
Medical Graphics Corp.
Anesthesiology · 288d
Cleared Jun 24, 2016
Liger Medical HTU-110
K152843 · HGI
Liger Medical, LLC
Obstetrics & Gynecology · 269d
Cleared Jun 24, 2016
Digital Blood Pressure Monitor
K153033 · DXN
Suzhou Sunspiri Co., Ltd.
Cardiovascular · 249d
Cleared Jun 24, 2016
SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor...
K153201 · NBW
Sd Biosensor
Chemistry · 233d
Cleared Jun 24, 2016
AnyPlus® Cervical PEEK Cage System
K153517 · ODP
GS Medical Co., Ltd.
Orthopedic · 199d
Cleared Jun 24, 2016
Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
K153692 · CGA
Infrared Laboratory Systems, LLC (Dba...
Chemistry · 184d
Cleared Jun 24, 2016
Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next...
K160430 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 129d
Cleared Jun 24, 2016
Naya Breast Pump System
K160511 · HGX
Naya Health, Inc.
Obstetrics & Gynecology · 121d
Cleared Jun 24, 2016
BrightMatter Guide with BrightMatter Pointer
K160523 · HAW
Synaptive Medical, Inc.
Neurology · 120d
Cleared Jun 24, 2016
ClariFix Device
K160669 · GEH
Arrinex, Inc.
General & Plastic Surgery · 107d
Cleared Jun 24, 2016
Ultrathane Endoureterotomy Stent Set
K160891 · FAD
Cook Incorporated
Gastroenterology & Urology · 85d
Cleared Jun 24, 2016
Precision Treatment Planning System
K161136 · MUJ
Accuray Incorporated
Radiology · 63d
Cleared Jun 24, 2016
iDMS Data Management System
K161144 · IYE
Accuray Incorporated
Radiology · 63d
Cleared Jun 24, 2016
Radixact Treatment Delivery System
K161146 · IYE
Accuray Incorporated
Radiology · 63d
Cleared Jun 24, 2016
CareEvent inclusive of the CareEvent Mobile Application accessory
K161164 · MSX
Philips Medical Systems
Cardiovascular · 60d
Cleared Jun 24, 2016
Single Use Surgical Suction Irrigator
K161421 · GCJ
Jiangsu Haize Medical Scientific...
General & Plastic Surgery · 32d
Cleared Jun 24, 2016
SMR Shoulder System
K161476 · KWT
Lima Corporate S.P.A.
Orthopedic · 28d
Cleared Jun 23, 2016
QiF Blood and Fluid Warmer
K150404 · LGZ
Quality IN Flow , Ltd.
General Hospital · 491d
Cleared Jun 23, 2016
Collagen Dental Wound Dressings
K152600 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 286d
Cleared Jun 23, 2016
EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
K152937 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 262d
Cleared Jun 23, 2016
Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology...
K153006 · NLH
Sterilmed, Inc.
Cardiovascular · 253d
Cleared Jun 23, 2016
CELALUX 3
K153018 · EBZ
Voco GmbH
Dental · 252d
Cleared Jun 23, 2016
FitRite™ Total Hip Arthroplasty System
K153057 · JDI
Excera Orthopedics, Inc.
Orthopedic · 246d