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
313–336 of 474
Search insights Median review: 294d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Oct 28, 2016
BD MAX Vaginal Panel, BD MAX Instrument
DEN160001 · PQA
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 291d
Not Cleared Oct 06, 2016
APAS Compact with Urine Analysis Module
DEN150059 · PPU
Clever Culture Systems AG
Microbiology · 287d
Not Cleared Sep 26, 2016
Sensor Monitored Alimentary Restriction Therapy (SMART) Device
DEN150033 · ONY
Scientific Intake
Gastroenterology & Urology · 423d
Not Cleared Sep 16, 2016
Acclarent Aera Eustachian Tube Balloon Dilation System
DEN150056 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 284d
Not Cleared Sep 02, 2016
Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP...
DEN150049 · POL
Concentric Medical, Inc.
Neurology · 312d
Not Cleared Aug 22, 2016
ImPACT Computerized Neurocognitive Concussion Management Aid
DEN150037 · POM
Impact Applications, Inc.
Neurology · 377d
Not Cleared Aug 01, 2016
Nautilus BrainPulse 1000
DEN140040 · POP
Jan Medical, Inc.
Neurology · 587d
Not Cleared Jul 27, 2016
Permaseal
DEN150029 · PNQ
Micro Interventional Devices,Inc.
Cardiovascular · 401d
Not Cleared Jul 22, 2016
Quantidex qPCR BCR-ABL IS Kit
DEN160003 · OYX
Asuragen, Inc.
Medical Genetics · 185d
Not Cleared Jul 15, 2016
EPIC ClearView System
DEN150004 · PNA
Epic Research & Diagnostics, Inc.
Neurology · 549d
Not Cleared Jun 13, 2016
Magnetic Surgical System
DEN150007 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 489d
Not Cleared Jun 08, 2016
PEDIATRIC VISION SCANNER
DEN130051 · PMW
Rebiscan, Inc.
Ophthalmic · 908d
Not Cleared Jun 03, 2016
WallFlex Biliary RX Fully Covered Stent System RMV
DEN150040 · PNB
Boston Scientific
Gastroenterology & Urology · 280d
Not Cleared May 13, 2016
Cereve Sleep System
DEN140032 · PLU
Cereve, Inc.
Neurology · 571d
Not Cleared Apr 25, 2016
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
DEN150030 · PNI
Kronus, Inc.
Immunology · 298d
Not Cleared Apr 20, 2016
GLAUCOMA COMPANION
DEN140022 · PLX
Innovatex, Inc.
Ophthalmic · 642d
Not Cleared Apr 07, 2016
PneumoLiner
DEN150028 · PMU
Advanced Surgical Concepts, Ltd.
Obstetrics & Gynecology · 293d
Not Cleared Mar 28, 2016
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II,...
DEN150058 · PMN
Bio-Rad Laboratories
Microbiology · 103d
Not Cleared Mar 04, 2016
SENSIMED TRIGGERFISH
DEN140017 · PLZ
Sensimed AG
Ophthalmic · 668d
Not Cleared Feb 20, 2016
B.R.A.H.M.S PCT sensitive KRYPTOR
DEN150009 · PMT
Brahms GmbH
Microbiology · 353d
Not Cleared Dec 23, 2015
cNEP Airway
DEN140024 · PMB
Sommetrics
Anesthesiology · 492d
Not Cleared Dec 18, 2015
Newa Skin Therapy System
DEN150005 · PAY
Endymed Medical, Ltd.
General & Plastic Surgery · 336d
Not Cleared Dec 08, 2015
Dignitana AB DigniCap System
DEN150010 · PMC
Dignitana AB
General & Plastic Surgery · 277d
Not Cleared Nov 20, 2015
RELIZORB
DEN150001 · PLQ
Alcresta, Inc.
Gastroenterology & Urology · 322d