FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Not cleared only ×
487 results
385–408 of 487
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Mar 28, 2014
IOGYN SYSTEM
DEN130040 · PGT
Iogyn, Inc.
Obstetrics & Gynecology · 210d
Not Cleared Mar 21, 2014
SIMPLEXA HSV 1&2 DIRECT
DEN130049 · PGH
Focus Diagnostics
Microbiology · 116d
Not Cleared Mar 11, 2014
CEFALY
DEN120019 · PCC
Stx-Med Sprl
Neurology · 453d
Not Cleared Mar 04, 2014
AIRPURGE
DEN080009 · OKL
Anesthesia Safety Products, LLC
General Hospital · 1952d
Not Cleared Jan 29, 2014
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
DEN120023 · PGD
Given Imaging , Ltd.
Gastroenterology & Urology · 426d
Not Cleared Jan 28, 2014
PROSTATE IMMOBILIZER RECTAL BALLOON
DEN130036 · PCT
Radiadyne
Radiology · 197d
Not Cleared Jan 17, 2014
CYTOSCAN(R) DX
DEN130018 · PFX
Affymetrix, Inc.
Pathology · 30d
Not Cleared Dec 18, 2013
RESTLESS LEG DEVICE
DEN110009 · OTX
Mary M. Sorg (An Individual) Dba PJ...
Neurology · 1056d
Not Cleared Dec 18, 2013
SYMPHONY DEVICE
DEN110011 · OVP
Sensory Medical, Inc.
Neurology · 889d
Not Cleared Dec 18, 2013
AXIOS STENT AND DELIVERY SYSTEM
DEN130007 · PCU
Xlumena, Inc.
Gastroenterology & Urology · 302d
Not Cleared Dec 13, 2013
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR
DEN130022 · OKP
Eneura Therapeutics
Neurology · 283d
Not Cleared Nov 19, 2013
ILLUMINA MISEQDX PLATFORM
DEN130011 · PFF
Illumina, Inc.
Chemistry · 57d
Not Cleared Nov 19, 2013
MISEQDX UNIVERSAL KIT 1.0
DEN130042 · PFT
Illumina, Inc.
Chemistry · 46d
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