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
217–240 of 474
Search insights Median review: 294d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Dec 28, 2018
EyeBOX
DEN170091 · QEA
Oculogica, Inc.
Neurology · 371d
Not Cleared Dec 21, 2018
MLL (KMT2A) Breakapart FISH Probe Kit
DEN170070 · QDI
Cytocell, Ltd.
Medical Genetics · 448d
Not Cleared Dec 21, 2018
Miris Human Milk Analyzer
DEN180007 · QEI
Miris AB
Chemistry · 312d
Not Cleared Dec 20, 2018
SEM Scanner (Model 200)
DEN170021 · QEF
Bruin Biometrics, LLC
Gastroenterology & Urology · 626d
Not Cleared Dec 20, 2018
Enlight 1810
DEN170072 · QEB
Timpel, Inc.
Anesthesiology · 447d
Not Cleared Dec 12, 2018
Retrograde Intubation Set
DEN170055 · QCX
Cook Incorporated
Anesthesiology · 443d
Not Cleared Nov 30, 2018
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
DEN180040 · QDZ
Meridian Bioscience, Inc.
Microbiology · 123d
Not Cleared Nov 19, 2018
QMS Plazomicin Immunoassay
DEN180030 · QDR
Microgenics Corporation
Toxicology · 147d
Not Cleared Nov 06, 2018
Innovo
DEN170049 · QAJ
Bio-Medical Research, Ltd.
Gastroenterology & Urology · 414d