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
313–336 of 483
Search insights Median review: 299d Top manufacturer: Biofire Diagnostics, LLC Lead specialty: Microbiology
Not Cleared Feb 14, 2017
FilmArray NGDS Warrior Panel
DEN160048 · PRD
Biofire Defense, LLC
Microbiology · 120d
Not Cleared Feb 06, 2017
Variola virus Real-Time PCR Assay
DEN160016 · PRA
Centers For Disease Control and...
Microbiology · 298d
Not Cleared Feb 03, 2017
SEEKER System
DEN150035 · PQW
Baebies, Inc.
Chemistry · 548d
Not Cleared Dec 21, 2016
AeroForm Tissue Expander System
DEN150055 · PQN
Airxpanders, Inc.
General & Plastic Surgery · 380d
Not Cleared Dec 21, 2016
CipherOx CRI Tablet
DEN160020 · PPW
Flashback Technologies, Inc.
Cardiovascular · 211d
Not Cleared Dec 20, 2016
Ultravision Visual Clearing System
DEN150022 · PQM
Alesi Surgical, Ltd.
General Hospital · 574d
Not Cleared Dec 19, 2016
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
DEN150057 · PQO
Roche Diagnostics
Chemistry · 376d
Not Cleared Dec 19, 2016
Hem-Avert Perianal Stabilizer
DEN160005 · PNU
Stetrix, Inc.
Obstetrics & Gynecology · 326d
Not Cleared Dec 16, 2016
CleanCisionTM Wound Retraction and Protection System
DEN150038 · PQI
Prescient Surgical
General & Plastic Surgery · 491d
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