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
433–456 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Mar 16, 2007
XPERT EV, MODEL GXEV-100N-10
DEN070004 · OAI
Cepheid
Microbiology · 4d
Not Cleared Feb 08, 2007
TEPHAFLEX ABSORBABLE SUTURE
DEN060003 · NWJ
Tepha, Inc.
General & Plastic Surgery · 272d
Not Cleared Feb 06, 2007
MAMMAPRINT
DEN070009 · NYI
Agendia BV
Pathology · 7d
Not Cleared Jan 30, 2007
COMPUTERIZED LABOR MONITORING SYSTEM
DEN060006 · NPB
Barnev, Ltd.
Obstetrics & Gynecology · 104d
Not Cleared Oct 12, 2006
INTROL CF PANEL I CONTROL
DEN060007 · NZB
Maine Molecular Quality Controls, Inc.
Pathology · 59d
Not Cleared Apr 26, 2006
PHICAL TEST
DEN060001 · NXO
Genova Diagnostics
Immunology · 34d
Not Cleared Mar 27, 2006
HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
DEN050007 · NRK
Fmg Innovations, Inc.
Ear, Nose, Throat · 280d
Not Cleared Feb 03, 2006
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET
DEN060008 · NXD
Centers For Disease Control and...
Microbiology · 7d