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
385–408 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared May 09, 2014
PIXEL 3 SYSTEM
DEN130015 · PBZ
Gauss Surgical, Inc.,
General & Plastic Surgery · 459d
Not Cleared Apr 16, 2014
LYRA DIRECT STREP ASSAY
DEN140005 · PGX
Quidel Corporation
Microbiology · 22d
Not Cleared Apr 03, 2014
XSTAT
DEN130016 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 428d
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