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
1–24 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Jul 28, 2026
CaRi-Heart
DEN250042 · SIU
Caristo Diagnostics , Ltd.
Cardiovascular · 327d
Not Cleared Jul 21, 2026
OTTAVA™ Robotic Surgical System
DEN250068 · NAY
Auris Health, Inc., part of Johnson &...
General & Plastic Surgery · 215d
Not Cleared Jul 17, 2026
SportSuite Vision Software
DEN250040 · SIT
Stryker Endoscopy
Orthopedic · 318d
Not Cleared Jul 06, 2026
TESSA Spatial Surgery System
DEN250037 · SIQ
Smith & Nephew, Inc.
Orthopedic · 318d
Not Cleared Jul 02, 2026
Claria System
DEN250034 · SIM
Claria Medical, Inc.
Obstetrics & Gynecology · 329d
Not Cleared Jun 18, 2026
Syncron-E
DEN250025 · QVC
Autonomous Healthcare, Inc.
Anesthesiology · 360d
Not Cleared May 22, 2026
PCWP Analysis Software
DEN250057 · SIF
Cardiosense, Inc.
Cardiovascular · 186d
Not Cleared May 21, 2026
DeepView AI® System
DEN250028 · SHY
Spectralmd, Inc.
General & Plastic Surgery · 328d
Not Cleared May 08, 2026
Modius Spero
DEN250013 · SHX
Neurovalens Limited
Neurology · 387d
Not Cleared May 01, 2026
Prolystica Pass Thru Disinfectant Wipes
DEN240075 · SHM
Steris
General Hospital · 505d
Not Cleared Apr 30, 2026
Aurie System
DEN250023 · SHV
Cathbuddy, Inc.
Gastroenterology & Urology · 328d
Not Cleared Apr 17, 2026
XplantR Explant Tool
DEN250033 · SHR
Hjarta Care, LLC
Cardiovascular · 253d
Not Cleared Apr 03, 2026
neuropacs
DEN240071 · SHO
Automated Imaging Diagnostics, LLC
Neurology · 485d
Not Cleared Mar 17, 2026
Tyto Insights for Eardrum Bulging Detection
DEN250014 · SHL
Tyto Care , Ltd.
Ear, Nose, Throat · 330d
Not Cleared Mar 04, 2026
LifeVac
DEN250012 · QXN
Lifevac, LLC
Ear, Nose, Throat · 327d
Not Cleared Feb 11, 2026
Delivery Date AI
DEN250007 · SHE
Ultrasound AI
Radiology · 331d
Not Cleared Feb 06, 2026
Amferia Wound Dressing
DEN250006 · SHA
Amferia AB
General & Plastic Surgery · 340d
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