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
409–432 of 474
Search insights Median review: 294d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Jan 20, 2012
STRATIFY JCV(TM) ANTIBODY
DEN120008 · OYP
Focus Diagnostics, Inc.
Microbiology · 14d
Not Cleared Dec 20, 2011
VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50
DEN100013 · OSZ
Vioguard
General Hospital · 410d
Not Cleared Dec 13, 2011
INFRASCANNER, MODEL 1000
DEN100002 · OPT
Infrascan, Inc.
Neurology · 614d
Not Cleared Nov 21, 2011
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH...
DEN100026 · OTD
Aptus Endosystems, Inc.
Cardiovascular · 342d
Not Cleared Jun 28, 2011
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
DEN100017 · ORZ
Tearscience, Inc.
Ophthalmic · 323d
Not Cleared Apr 19, 2011
APTIMA TRICHOMONAS VAGINALIS ASSAY
DEN110012 · OUY
Gen-Probe Incorporated
Microbiology · 6d
Not Cleared Apr 08, 2011
DENV DETECT IGM CAPTURE ELISA
DEN100020 · OSU
Inbios Intl., Inc.
Microbiology · 170d
Not Cleared Mar 31, 2011
MANDOMETER III
DEN070014 · OBV
Ab Mando
Neurology · 1380d
Not Cleared Mar 31, 2011
WIDEXLINK IN CLEAR SERIES HEARING AIDS
DEN100025 · OSM
Office Research IN Clinical Amplifiction
Ear, Nose, Throat · 169d
Not Cleared Feb 23, 2011
RIDASCREEN NOROVIRUS 3RD GENERATION EIA
DEN110001 · OUC
R-Biopharm AG
Microbiology · 7d
Not Cleared Jan 13, 2011
HEM-AVERT PERIANAL STABILIZER
DEN090011 · OOA
Plexus Biomedical, Inc.
Obstetrics & Gynecology · 513d
Not Cleared Aug 24, 2010
ZELTIQ AESTHETICS DERMAL COOLING DEVICE
DEN090002 · OOK
Zeltiq Aesthetics
General & Plastic Surgery · 315d
Not Cleared Aug 24, 2010
ERCHONIA ML SCANNER (MLS)
DEN090008 · OLI
Erchonia Medical
General & Plastic Surgery · 596d
Not Cleared Apr 30, 2010
PRINEO SKIN CLOSURE SYSTEM
DEN090005 · OMD
Closure Medical Corp.
General & Plastic Surgery · 402d
Not Cleared Sep 11, 2009
ULTHERA SYSTEM, MODEL 8850-0001
DEN080006 · OHV
Ulthera, Inc.
General & Plastic Surgery · 518d
Not Cleared Sep 11, 2009
OVA1 TEST
DEN090004 · ONX
Vermillion
Immunology · 51d
Not Cleared Aug 07, 2009
SNAP WOUND CARE DEVICE
DEN080011 · OKO
Spiracur, Inc.
General & Plastic Surgery · 277d
Not Cleared Feb 25, 2009
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
DEN070002 · NYS
Quick-Med Technologies, Inc.
General & Plastic Surgery · 657d
Not Cleared Oct 07, 2008
NEUROSTAR TMS SYSTEM
DEN070003 · OBP
Neuronetics
Neurology · 502d
Not Cleared Aug 26, 2008
ALLOMAP MOLECULAR EXPRESSION TESTING
DEN080007 · OJQ
Xdx
Chemistry · 11d
Not Cleared Jan 03, 2008
ID-TAG RESPIRATORY VIRAL PANEL
DEN070013 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 30d
Not Cleared Jun 13, 2007
INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM
DEN060002 · NZH
Inrange Systems, Inc.
General Hospital · 265d
Not Cleared Jun 13, 2007
BINAX NOW MALARIA TEST
DEN070006 · OAX
Inverness Medical Professional...
Microbiology · 82d
Not Cleared May 08, 2007
3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE
DEN060009 · NZJ
3M Company
General Hospital · 217d