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
265–288 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Jun 22, 2018
Ellipsys Vascular Access System
DEN170004 · PQK
Avenu Medical, Inc.
Cardiovascular · 528d
Not Cleared Jun 12, 2018
DreaMed Advisor Pro
DEN170043 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 299d
Not Cleared Jun 05, 2018
Curve Positive Airway Pressure System
DEN170089 · QBY
Fresca Medical
Anesthesiology · 173d
Not Cleared May 24, 2018
OsteoDetect
DEN180005 · QBS
Imagen Technologies, Inc.
Radiology · 108d
Not Cleared May 17, 2018
TrueTear Intranasal Tear Neurostimulator
DEN170086 · QBR
Allergan
Ophthalmic · 206d
Not Cleared May 07, 2018
Hemospray Endoscopic Hemostat
DEN170015 · QAU
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 424d
Not Cleared Apr 26, 2018
Cala ONE
DEN170028 · QBC
Cala Health, Inc.
Neurology · 344d
Not Cleared Apr 20, 2018
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
DEN170010 · QBK
Lin-Zhi International, Inc.
Toxicology · 423d
Not Cleared Apr 20, 2018
MALDI Biotyper CA System
DEN170081 · QBN
Bruker Daltonik GmbH
Microbiology · 203d
Not Cleared Apr 11, 2018
IDx-DR
DEN180001 · PIB
Idx, LLC
Ophthalmic · 89d
Not Cleared Apr 10, 2018
Precision Flow® HVNI
DEN170001 · QAV
Vapotherm, Inc.
Anesthesiology · 462d
Not Cleared Apr 03, 2018
Curetis Unyvero LRT Application
DEN170047 · QBH
Curetis GmbH
Microbiology · 204d
Not Cleared Mar 27, 2018
Dexcom G6 Continuous Glucose Monitoring System
DEN170088 · QBJ
Dexcom, Inc.
Chemistry · 109d
Not Cleared Mar 26, 2018
ThermoNeuroModulation Device, TNM Device
DEN170023 · QAR
Scion Neurostim, LLC
Neurology · 343d
Not Cleared Mar 19, 2018
PrimeStore MTM
DEN170029 · QBD
Longhorn Vaccines and Diagnostics, LLC
Microbiology · 299d
Not Cleared Mar 16, 2018
Acumen Hypotension Prediction Index (HPI) Feature Software
DEN160044 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 536d
Not Cleared Mar 06, 2018
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
DEN170046 · QAZ
23AndMe, Inc.
Pathology · 182d
Not Cleared Mar 01, 2018
SkinPen Precision System
DEN160029 · QAI
Bellus Medical, LLC
General & Plastic Surgery · 604d
Not Cleared Feb 14, 2018
Banyan BTI
DEN170045 · QAT
Banyan Biomarkers, Inc.
Immunology · 170d
Not Cleared Feb 13, 2018
ContaCT
DEN170073 · QAS
Viz.Al, Inc.
Radiology · 137d
Not Cleared Dec 28, 2017
dermaPACE System
DEN160037 · PZL
Sanuwave, Inc.
General & Plastic Surgery · 521d
Not Cleared Dec 22, 2017
remOVE System
DEN160014 · QAG
Ovesco Endoscopy AG
Gastroenterology & Urology · 620d
Not Cleared Dec 21, 2017
AQUABEAM System
DEN170024 · PZP
Procept Biorobotics, Corporation
Gastroenterology & Urology · 248d
Not Cleared Dec 19, 2017
IlluminOss Bone Stabilization System
DEN160062 · QAD
Illminoss Medical, Inc.
Orthopedic · 356d