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
25–48 of 490
Search insights Median review: 299d Top manufacturer: Biofire Diagnostics, LLC Lead specialty: Microbiology
Not Cleared Jan 16, 2026
Sana Device
DEN250005 · QYN
Sana Health
Neurology · 319d
Not Cleared Jan 15, 2026
VitaSmart Hypothermic Oxygenated Perfusion System
DEN250009 · SGY
Bridge TO Life, Ltd.
Gastroenterology & Urology · 290d
Not Cleared Dec 23, 2025
QIKCAP System
DEN250004 · SGX
Hai Solutions
General Hospital · 327d
Not Cleared Dec 23, 2025
LIAISON® XL MUREX Anti-HDV (318260)
DEN250032 · SGW
DiaSorin, Inc.
Microbiology · 146d
Not Cleared Nov 26, 2025
MuReva OM™
DEN240077 · SGQ
Mureva Phototherapy, Inc.
Dental · 338d
Not Cleared Nov 14, 2025
Neurolyser XR (NXR100)
DEN250015 · SGN
Fusmobile, Inc.
Neurology · 203d
Not Cleared Oct 31, 2025
Pulsenmore ES
DEN240074 · SGJ
Pulsenmore, Ltd.
Radiology · 324d
Not Cleared Oct 17, 2025
Modius Lean
DEN240076 · SFW
Neurovalens Limited
Gastroenterology & Urology · 303d
Not Cleared Oct 06, 2025
PainChek (PainChek Adult)
DEN240073 · SGB
Painchek Limited (Ltd.)
Neurology · 299d
Not Cleared Oct 03, 2025
ProSense™ System
DEN220077 · QXW
Icecure Medical
General & Plastic Surgery · 1080d
Not Cleared Sep 25, 2025
Essilor® Stellest®
DEN250016 · QUR
Essilor of America, Inc.
Ophthalmic · 150d
Not Cleared Sep 23, 2025
Biolinq Shine Autonomous Time-in-Range Microsensor
DEN240080 · SFU
Biolinq Incorporated
Chemistry · 270d
Not Cleared Sep 19, 2025
KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
DEN240067 · SFS
Cytocell Limited
Medical Genetics · 301d
Not Cleared Aug 20, 2025
Delphi-MD System
DEN250002 · SFN
Quantalx Neuroscience, Ltd.
Neurology · 229d
Not Cleared Jul 31, 2025
ArteraAI Prostate
DEN240068 · SFH
Artera, Inc.
Pathology · 248d
Not Cleared Jun 17, 2025
Oxiplex®
DEN240038 · QVL
Fziomed, Inc.
Orthopedic · 330d
Not Cleared Jun 17, 2025
COAPTIUM Connect with TISSIUM LIGHT
DEN240066 · SFD
Tissium SA
Neurology · 208d
Not Cleared Jun 12, 2025
APO-Easy Genotyping kit
DEN240032 · SFC
Firalis SA
Immunology · 356d
Not Cleared May 30, 2025
Allix5
DEN240047 · SEZ
Clairity, Inc.
Radiology · 266d
Not Cleared May 29, 2025
Spur Peripheral Retrievable Stent System
DEN240048 · SEU
Reflow Medical, Inc.
Cardiovascular · 251d
Not Cleared May 22, 2025
ConcizuTrace™ ELISA
DEN240035 · SES
Randox Laboratories, Ltd.
Hematology · 325d
Not Cleared May 09, 2025
Teal Wand
DEN240045 · SEP
Teal Health, Inc.
Microbiology · 255d
Not Cleared Apr 17, 2025
Minder System
DEN240062 · SEM
Epi-Minder Pty, Ltd.
Neurology · 181d
Not Cleared Apr 11, 2025
CT-132
DEN240064 · SEE
Click Therapeutics, Inc.
Neurology · 150d