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
385–408 of 474
Search insights Median review: 294d Top manufacturer: Biofire Diagnostics, LLC Lead specialty: Microbiology
Not Cleared Sep 13, 2013
UROLIFT SYSTEM
DEN130023 · PEW
Neotract, Inc.
Gastroenterology & Urology · 190d
Not Cleared Aug 21, 2013
VITEK MS
DEN130013 · PEX
bioMerieux, Inc.
Microbiology · 231d
Not Cleared Aug 08, 2013
QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
DEN130005 · PDY
Centers For Disease Control and...
Toxicology · 72d
Not Cleared Jul 29, 2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
DEN130010 · PDO
Abbott Molecular, Inc.
Pathology · 111d
Not Cleared Jul 25, 2013
XPERT MTB/RIF ASSAY
DEN130032 · PEU
Cepheid
Microbiology · 44d
Not Cleared Jul 15, 2013
NEBA SYSTEM
DEN110019 · NCG
Lexicor Medical Technology, LLC
Neurology · 585d
Not Cleared Jul 12, 2013
CABOCHON SYSTEM
DEN110004 · OUP
Cabochon Aesthetics, Inc.
General & Plastic Surgery · 620d
Not Cleared Jul 12, 2013
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
DEN110006 · OWP
STERIS Corporation
General Hospital · 675d
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