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
433–456 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Oct 28, 2005
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
DEN050006 · NQH
Cardiomems, Inc.
Cardiovascular · 80d
Not Cleared May 19, 2005
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
DEN050002 · NSF
Wako Chemicals USA, Inc.
Immunology · 42d
Not Cleared May 09, 2005
TAG-IT CYSTIC FIBROSIS KIT
DEN050004 · NUA
Tm Bioscience Corporation
Pathology · 34d
Not Cleared Apr 18, 2005
DECAPINOL ORAL RINSE
DEN050001 · NTO
Sinclair Pharmaceuticals Limited
Dental · 84d
Not Cleared Apr 18, 2005
PAXGENE BLOOD RNA SYSTEM
DEN050003 · NTW
Preanalytix GmbH
Pathology · 49d
Not Cleared Dec 23, 2004
AMPLICHIP CYP450 TEST, MODEL 04381866190
DEN040011 · NTI
Roche Molecular Systems, Inc.
Chemistry · 3d
Not Cleared Dec 23, 2004
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
DEN040012 · NSU
Affymetrix, Inc.
Toxicology · 50d