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
265–288 of 474
Search insights Median review: 294d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Dec 19, 2017
ContainOR
DEN170075 · PZQ
Advanced Surgical Concepts, Ltd.
General & Plastic Surgery · 81d
Not Cleared Nov 29, 2017
GeneSTAT.MDx Coccidioides Assay
DEN170041 · QAA
Dxna, LLC
Microbiology · 120d
Not Cleared Nov 24, 2017
FilmArray Respiratory Panel 2 plus (RP2plus)
DEN170017 · PZF
Biofire Diagnostics, LLC
Microbiology · 253d
Not Cleared Nov 15, 2017
NSS-2 System
DEN170018 · PZR
Innovative Health Solutions (Ihs), Inc.
Neurology · 243d
Not Cleared Nov 15, 2017
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a...
DEN170058 · PZM
Memorial Sloan-Kettering Cancer Center
Pathology · 51d
Not Cleared Oct 27, 2017
VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2...
DEN170030 · PZJ
Ventana Medical Systems
Pathology · 150d
Not Cleared Sep 14, 2017
reSet
DEN160018 · PWE
Pear Therapeutics, Inc.
Neurology · 486d
Not Cleared Aug 18, 2017
ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax...
DEN160025 · PYN
Id-Fish Technology, Inc.
Microbiology · 417d
Not Cleared Jul 27, 2017
FETAL PILLOW
DEN150053 · PWB
Safe Obstetric Systems, Ltd.
Obstetrics & Gynecology · 617d