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
25–48 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Apr 09, 2025
Tango® Belt (Model SAS-001-01 (XS)
DEN240021 · SEC
Active Protective Technologies, Inc.
Physical Medicine · 328d
Not Cleared Apr 04, 2025
Prapela SVS hospital bassinet pad (model P01)
DEN240031 · QVY
Prapela, Inc.
General Hospital · 291d
Not Cleared Mar 28, 2025
Visby Medical Women's Sexual Health Test
DEN240020 · SEA
Visby Medical, Inc.
Microbiology · 319d
Not Cleared Mar 19, 2025
CORIS System
DEN240018 · SEW
Nanosonics Limited
General Hospital · 322d
Not Cleared Jan 17, 2025
Myocene
DEN230051 · SDX
Myocene
Physical Medicine · 540d
Not Cleared Dec 19, 2024
ARC-EX System
DEN240014 · SDO
Onward Medical, Inc.
Neurology · 266d
Not Cleared Dec 05, 2024
VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
DEN240025 · SDP
Ventana Medical Systems, Inc.
Pathology · 190d