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
217–240 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Feb 10, 2020
Surfacer Inside-Out Access Catheter System
DEN190038 · QJH
Bluegrass Vascular Technologies, Inc.
Cardiovascular · 179d
Not Cleared Feb 07, 2020
Caption Guidance
DEN190040 · QJU
Bay Labs, Inc.
Radiology · 164d
Not Cleared Dec 23, 2019
Mucosal Integrity Conductivity (MI) Test System
DEN180067 · QIS
Diversatek Healthcare, Inc.
Gastroenterology & Urology · 371d
Not Cleared Dec 13, 2019
Control-IQ Technology
DEN190034 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 151d
Not Cleared Dec 12, 2019
GSP Neonatal Creatine Kinase - MM kit
DEN180056 · QJE
Perkinelmer, Inc.
Chemistry · 427d
Not Cleared Dec 05, 2019
cobas vivoDx MRSA
DEN190016 · QIV
Roche Molecular Systems, Inc.
Microbiology · 261d
Not Cleared Dec 02, 2019
WOUNDCHEK Bacterial Status
DEN180014 · QFA
Alere Scarborough, Inc.
Microbiology · 619d
Not Cleared Nov 20, 2019
EchoTip Insight Portosystemic Pressure Gradient Measuring System
DEN180062 · QIJ
Cook Ireland, Ltd.
Gastroenterology & Urology · 366d
Not Cleared Oct 10, 2019
OraQuick Ebola Rapid Antigen Test
DEN190025 · QID
OraSure Technologies, Inc.
Microbiology · 150d
Not Cleared Jun 07, 2019
IB-Stim
DEN180057 · QHH
Innovative Health Solutions (Ihs), Inc.
Neurology · 225d
Not Cleared May 23, 2019
Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin...
DEN180032 · QGN
Cd Diagnostics, Inc.
Microbiology · 328d
Not Cleared May 23, 2019
ZIKV Detect 2.0 IgM Capture ELISA
DEN180069 · QFO
InBios International, Inc.
Microbiology · 148d
Not Cleared May 20, 2019
Nerivio Migra
DEN180059 · QGT
Theranica Bioelectronics , Ltd.
Neurology · 195d
Not Cleared Apr 24, 2019
Comaneci, Comaneci Petit, Comaneci 17
DEN170064 · PUU
Rapid Medical , Ltd.
Neurology · 573d
Not Cleared Apr 19, 2019
PREVENA 125 and PREVENA PLUS 125 Therapy Units
DEN180013 · QFC
Kci USA, Inc.
General & Plastic Surgery · 400d
Not Cleared Apr 19, 2019
Monarch eTNS System
DEN180041 · QGL
Neurosigma, Inc.
Neurology · 263d
Not Cleared Apr 12, 2019
Plenity
DEN180060 · QFQ
Gelesis, Inc.
Gastroenterology & Urology · 148d
Not Cleared Mar 28, 2019
LOADPRO™ Intraoperative Rod Strain Sensor
DEN180012 · QFP
Intellirod Spine, Inc.
Orthopedic · 379d
Not Cleared Mar 28, 2019
Leica FL400
DEN180024 · QFX
Leica Microsystems (Schweiz) AG
Neurology · 335d
Not Cleared Mar 14, 2019
ClearMate
DEN170044 · QFB
Thornhill Research, Inc.
Anesthesiology · 573d
Not Cleared Mar 12, 2019
Quantra Hemostasis Analyzer, QPlus Cartridge
DEN180017 · QFR
Hemosonics, LLC
Hematology · 344d
Not Cleared Mar 01, 2019
Early Bird Bleed Monitoring System
DEN180021 · QFJ
Saranas, Inc.
Cardiovascular · 312d
Not Cleared Feb 14, 2019
t:slim X2 insulin pump with interoperable technology
DEN180058 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 108d
Not Cleared Jan 23, 2019
Aptima Mycoplasma genitalium Assay
DEN180047 · QEP
Hologic, Inc.
Microbiology · 145d