Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Not cleared only ×
490 results
169–192 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Jan 07, 2022
Sunrise Sleep Disorder Diagnostic Aid
DEN210015 · QRS
Sunrise
Anesthesiology · 280d
Not Cleared Dec 21, 2021
CavaClear Laser Sheath
DEN210024 · QRJ
Spectranetics, Inc.
Cardiovascular · 179d
Not Cleared Dec 10, 2021
Comfort Marker 2.0.
DEN200041 · QRN
Medical Precision BV
Radiology · 536d
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