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
433–456 of 474
Search insights Median review: 294d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Dec 13, 2004
VYSIS AUTOVYSION SYSTEM
DEN040010 · NTH
Vysis
Pathology · 61d
Not Cleared Nov 04, 2004
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
DEN040009 · MRX
Hamilton Thorne Biosciences
Obstetrics & Gynecology · 71d
Not Cleared Oct 12, 2004
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
DEN040007 · NRV
Digital Angel Corporation
General Hospital · 69d
Not Cleared Aug 24, 2004
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL...
DEN040002 · NQL
Perkinelmer Life Sciences, Inc.
Chemistry · 53d
Not Cleared Jul 28, 2004
CEDIA SIROLIMUS ASSAY
DEN040008 · NRP
Microgenics Corp.
Chemistry · 41d
Not Cleared Jun 25, 2004
CELLERATION MIST THERAPY SYSTEM
DEN040004 · NRB
Celleration
General & Plastic Surgery · 57d
Not Cleared May 21, 2004
GLUCATELL
DEN040003 · NQZ
Associates of Cape Cod, Inc.
Microbiology · 60d
Not Cleared Jan 21, 2004
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT
DEN040001 · NQI
Advanced Diagnostic Systems
Pathology · 19d
Not Cleared Dec 17, 2003
FACTOR V LEIDEN KIT
DEN030005 · NPQ
Roche Diagnostics Corp.
Pathology · 9d