FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Not cleared only ×
487 results
169–192 of 487
Search insights Median review: 299d Top manufacturer: Biofire Diagnostics, LLC Lead specialty: Microbiology
Not Cleared Dec 03, 2021
Klox Biophotonic LumiHeal System
DEN200005 · QPE
Klox Technlogies, Inc.
General & Plastic Surgery · 668d
Not Cleared Nov 23, 2021
vPatch
DEN210012 · QRC
Virility Medical
Gastroenterology & Urology · 238d
Not Cleared Nov 16, 2021
EaseVRx
DEN210014 · QRA
Appliedvr, Inc.
Physical Medicine · 231d
Not Cleared Nov 13, 2021
Hemolung Respiratory Assist System
DEN210006 · QOH
Alung Technologies, Inc.
Cardiovascular · 254d
Not Cleared Nov 03, 2021
OMNIgene GUT Dx
DEN200040 · QPO
DNA Genotek, Inc.
Microbiology · 506d
Not Cleared Oct 20, 2021
Luminopia One
DEN210005 · QQU
Luminopia, Inc.
Ophthalmic · 233d
Not Cleared Oct 01, 2021
iotaSOFT Insertion System - Drive Unit, Controller and Accessories
DEN190055 · QQH
Iotamotion, Inc.
Ear, Nose, Throat · 653d
Not Cleared Sep 21, 2021
Paige Prostate
DEN200080 · QPN
Paige.Ai
Pathology · 264d
Not Cleared Sep 08, 2021
FEops HEARTguide
DEN200030 · QQI
Feops NV
Cardiovascular · 489d
Not Cleared Aug 27, 2021
Canary Tibial Extension with Canary Health Implanted Reporting Processor...
DEN200064 · QPP
Canary Medical, Inc.
Orthopedic · 312d
Not Cleared Aug 23, 2021
SureTune4 Software
DEN210003 · QQC
Medtronic Neuromodulation
Neurology · 201d
Not Cleared Aug 20, 2021
ADVIA Centaur Enhanced Liver Fibrosis (ELF)
DEN190056 · QQB
Siemens Healthcare Diagnostics, Inc.
Chemistry · 603d
Not Cleared Aug 19, 2021
OsteoProbe
DEN210013 · QGQ
Active Life Scientific, Inc.
Orthopedic · 142d
Not Cleared Jul 12, 2021
InSpace Subacromial Tissue Spacer System
DEN200039 · QPQ
Ortho-Space , Ltd.
Orthopedic · 395d
Not Cleared Jun 02, 2021
Cognoa ASD Diagnosis Aid
DEN200069 · QPF
Cognoa, Inc.
Neurology · 211d
Not Cleared May 27, 2021
SafeBreak Vascular
DEN190043 · QOI
Site Saver, Inc. D/B/A Lineus Medical
General Hospital · 617d
Not Cleared Apr 23, 2021
Neurolutions Upper Extremity Rehabilitation System
DEN200046 · QOL
Neurolutions, Inc.
Physical Medicine · 274d
Not Cleared Apr 09, 2021
GI Genius
DEN200055 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 213d
Not Cleared Apr 01, 2021
Gili Pro BioSensor (also known as “Gili BioSensor System”)
DEN200038 · QOK
Continuse Biometrics , Ltd.
Cardiovascular · 293d
Not Cleared Mar 26, 2021
Oxehealth Vital Signs
DEN200019 · QME
Oxehealth Limited
Cardiovascular · 364d
Not Cleared Mar 26, 2021
Portable Neuromodulation Stimulator (PoNS)
DEN200050 · QCF
Helius Medical, Inc.
Neurology · 234d
Not Cleared Mar 17, 2021
BioFire Respiratory Panel 2.1 (RP2.1)
DEN200031 · QOF
Biofire Diagnostics, LLC
Microbiology · 302d
Not Cleared Mar 05, 2021
ClearUP Sinus Relief
DEN200006 · QNU
Tivic Health Systems, Inc.
Ear, Nose, Throat · 392d
Not Cleared Mar 01, 2021
Analytic for Hemodynamic Instability (AHI)
DEN200022 · QNV
Fifth Eye, Inc.
Cardiovascular · 332d