FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Not cleared only ×
474 results
337–360 of 474
Search insights Median review: 294d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Dec 18, 2014
AMIGO REMOTE CATHETER SYSTEM
DEN140009 · PJB
Catheter Robotics, Inc.
Cardiovascular · 303d
Not Cleared Dec 15, 2014
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
DEN140010 · PJI
Wallac OY
Pathology · 299d
Not Cleared Nov 26, 2014
HEARTFLOW FFRCT
DEN130045 · PJA
Heartflow
Cardiovascular · 387d
Not Cleared Nov 17, 2014
BrainScope Ahead 100
DEN140025 · PIW
Brainscope Company, Inc.
Neurology · 89d
Not Cleared Nov 07, 2014
ZAP-IT!
DEN100024 · OSG
Ecobrands , Ltd.
Neurology · 1520d
Not Cleared Nov 07, 2014
ZANZA-CLICK
DEN130019 · OSG
Tecnimed S.R.L.
Neurology · 617d
Not Cleared Oct 14, 2014
INFLOW INTRAURETHRAL VALVE-PUMP
DEN130044 · PIH
Vesiflo, Inc.
Gastroenterology & Urology · 354d
Not Cleared Sep 22, 2014
T2CANDIDA AND T2DX INSTRUMENT
DEN140019 · PII
T2biosystems, Inc.
Microbiology · 118d
Not Cleared Sep 05, 2014
NEPHROCHECK TEST SYSTEM
DEN130031 · PIG
Astute Medical, Inc.
Chemistry · 457d