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
409–432 of 490
Search insights Median review: 299d Top manufacturer: Biofire Diagnostics, LLC Lead specialty: Microbiology
Not Cleared May 23, 2013
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
DEN130002 · PDJ
Roche Diagnostics
Chemistry · 59d
Not Cleared May 09, 2013
X-RAY ATTENUATING CREAM
DEN120022 · PDK
Bloxr Corporation
Radiology · 183d
Not Cleared Jan 23, 2013
FERRISCAN R2-MRI ANALYSIS SYSTEM
DEN130012 · PCS
Resonance Health Analysis Services...
Radiology · 21d
Not Cleared Jan 14, 2013
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR...
DEN130003 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 3d
Not Cleared Dec 19, 2012
BIO-SEAL LUNG BIOPSY TRACT SYSTEM
DEN090007 · OMT
Angiotech
Anesthesiology · 1342d
Not Cleared Nov 20, 2012
AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
DEN100023 · OSD
National Center For Pelvic Pain...
Physical Medicine · 823d
Not Cleared Oct 18, 2012
VIRULITE COLD SORE MACHINE
DEN090012 · OKJ
Virulite, LLC
General & Plastic Surgery · 1206d
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