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
409–432 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Jul 10, 2012
PROTEUS INGESTION CONFINMATION SYSTEMS
DEN120011 · OZW
Proteus Biomedical, Inc.
Gastroenterology & Urology · 60d
Not Cleared Jun 26, 2012
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
DEN120014 · PAM
Nanosphere, Inc.
Microbiology · 11d
Not Cleared Jun 11, 2012
NUCLEUS-X PTV CATHETER
DEN080015 · OZT
NuMED, Inc.
Cardiovascular · 1265d
Not Cleared May 24, 2012
CDC DENV-1-4 REAL TIME RT-PCT ASSAY
DEN120012 · OZB
Centers For Disease Control and...
Microbiology · 73d
Not Cleared Apr 30, 2012
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
DEN110016 · OXT
Ethicon Endo-Surgery
General & Plastic Surgery · 222d
Not Cleared Apr 30, 2012
PORTRAIT ANALYZER
DEN120013 · OMN
Great Basin Scientific
Microbiology · 59d
Not Cleared Apr 27, 2012
PROSTATE MECHANICAL IMAGER
DEN100016 · OQT
Artann Laboratories, Inc.
Gastroenterology & Urology · 707d
Not Cleared Mar 30, 2012
SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
DEN110002 · OVY
STERIS Corporation
General Hospital · 242d
Not Cleared Feb 15, 2012
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR...
DEN120001 · OYL
Phadia US, Inc.
Immunology · 34d
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