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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Not cleared only ×
490 results
337–360 of 490
Search insights Median review: 299d Top manufacturer: Biofire Diagnostics, LLC Lead specialty: Microbiology
Not Cleared Jul 22, 2016
Quantidex qPCR BCR-ABL IS Kit
DEN160003 · OYX
Asuragen, Inc.
Medical Genetics · 185d
Not Cleared Jul 15, 2016
EPIC ClearView System
DEN150004 · PNA
Epic Research & Diagnostics, Inc.
Neurology · 549d
Not Cleared Jun 13, 2016
Magnetic Surgical System
DEN150007 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 489d
Not Cleared Jun 08, 2016
PEDIATRIC VISION SCANNER
DEN130051 · PMW
Rebiscan, Inc.
Ophthalmic · 908d
Not Cleared Jun 03, 2016
WallFlex Biliary RX Fully Covered Stent System RMV
DEN150040 · PNB
Boston Scientific
Gastroenterology & Urology · 280d
Not Cleared May 13, 2016
Cereve Sleep System
DEN140032 · PLU
Cereve, Inc.
Neurology · 571d
Not Cleared Apr 25, 2016
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
DEN150030 · PNI
Kronus, Inc.
Immunology · 298d
Not Cleared Apr 20, 2016
GLAUCOMA COMPANION
DEN140022 · PLX
Innovatex, Inc.
Ophthalmic · 642d
Not Cleared Apr 07, 2016
PneumoLiner
DEN150028 · PMU
Advanced Surgical Concepts, Ltd.
Obstetrics & Gynecology · 293d
Not Cleared Mar 28, 2016
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II,...
DEN150058 · PMN
Bio-Rad Laboratories
Microbiology · 103d
Not Cleared Mar 04, 2016
SENSIMED TRIGGERFISH
DEN140017 · PLZ
Sensimed AG
Ophthalmic · 668d
Not Cleared Feb 20, 2016
B.R.A.H.M.S PCT sensitive KRYPTOR
DEN150009 · PMT
Brahms GmbH
Microbiology · 353d
Not Cleared Dec 23, 2015
cNEP Airway
DEN140024 · PMB
Sommetrics
Anesthesiology · 492d
Not Cleared Dec 18, 2015
Newa Skin Therapy System
DEN150005 · PAY
Endymed Medical, Ltd.
General & Plastic Surgery · 336d
Not Cleared Dec 08, 2015
Dignitana AB DigniCap System
DEN150010 · PMC
Dignitana AB
General & Plastic Surgery · 277d
Not Cleared Nov 20, 2015
RELIZORB
DEN150001 · PLQ
Alcresta, Inc.
Gastroenterology & Urology · 322d
Not Cleared Nov 02, 2015
INVOcell
DEN150008 · OYO
Invo Bioscience
Obstetrics & Gynecology · 252d
Not Cleared Oct 09, 2015
Sonablate 450
DEN150011 · PLP
Sonacare Medical, LLC
Gastroenterology & Urology · 200d
Not Cleared Oct 08, 2015
FilmArray Meningitis/Encephalitis(ME) Panel
DEN150013 · PLO
Biofire Diagnostics, LLC
Microbiology · 182d
Not Cleared Sep 29, 2015
EarLens Contact Hearing Device
DEN150002 · PLK
Earlens Corporation
Ear, Nose, Throat · 270d
Not Cleared Jun 23, 2015
ESOPHAGEAL COOLING DEVICE
DEN140018 · PLA
Advanced Cooling Therapy, LLC
Cardiovascular · 410d
Not Cleared Jun 18, 2015
BRAINPORT V100 DEVICE
DEN130039 · PIC
Wicab, Inc.
Ophthalmic · 680d
Not Cleared Jun 05, 2015
COGNIVUE
DEN130033 · PKQ
Cerebral Assessment Systems, Inc.
Neurology · 723d
Not Cleared Apr 09, 2015
NOVA View Automated Fluorescense Microscope
DEN140039 · PIV
Inova Diagnostics, Inc.
Immunology · 115d