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
1–24 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Oct 30, 2026
Virtuoso Endoscopy System
DEN250054 · SJS
Virtuoso Surgical, Inc.
General & Plastic Surgery · 394d
Not Cleared Oct 20, 2026
Elecsys HBsAg II quant II RxDx
DEN260027 · SJM
Roche Diagnostics
Microbiology · 140d
Not Cleared Sep 29, 2026
SmartRead(TM) Medical Device Identifier (4100)
DEN260007 · SJJ
BridgeSource Medical Corporation
Cardiovascular · 189d
Not Cleared Aug 25, 2026
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
DEN250049 · SJD
Abbott Diabetes Care
Chemistry · 330d
Not Cleared Aug 21, 2026
ReneuRx™ (Neural Ice)
DEN250067 · SJA
Brixton Biosciences
Orthopedic · 249d
Not Cleared Aug 20, 2026
Qoramatic Automated Stool Management
DEN250043 · SJB
Cm Technologies, Inc.
Gastroenterology & Urology · 339d
Not Cleared Aug 19, 2026
Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)
DEN250046 · SIW
Vitestro
General Hospital · 327d
Not Cleared Jul 28, 2026
CaRi-Heart
DEN250042 · SIU
Caristo Diagnostics , Ltd.
Cardiovascular · 327d
Not Cleared Jul 21, 2026
OTTAVA™ Robotic Surgical System
DEN250068 · SIR
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