FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Not cleared only ×
483 results
337–360 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Apr 01, 2015
SpaceOAR System
DEN140030 · OVB
Augmenix, Inc.
Radiology · 182d
Not Cleared Mar 20, 2015
PROLONG
DEN130047 · PIA
Ergon Medical , Ltd.
Gastroenterology & Urology · 487d
Not Cleared Mar 06, 2015
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
DEN130046 · PKA
Somna Therapeutics, LLC
Ear, Nose, Throat · 477d
Not Cleared Feb 19, 2015
23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
DEN140044 · PKB
23AndMe
Chemistry · 266d
Not Cleared Feb 12, 2015
ECLIPSE SYSTEM
DEN140020 · PJH
Pelvalon
Gastroenterology & Urology · 233d
Not Cleared Jan 23, 2015
Dexcom Share Direct Secondary Displays
DEN140038 · PJT
Dexcom, Inc.
Chemistry · 39d
Not Cleared Dec 18, 2014
MOERAE SURGICAL MARKING PEN
DEN130004 · PDW
Moerae Matrix, Inc.
General & Plastic Surgery · 591d