FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Not cleared only ×
487 results
49–72 of 487
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Nov 13, 2024
SmartFlow Neuro Cannula
DEN240023 · SDG
ClearPoint Neuro, Inc.
Neurology · 175d
Not Cleared Nov 12, 2024
VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
DEN230085 · SDC
Steris
General Hospital · 330d
Not Cleared Nov 04, 2024
Valeda Light Delivery System
DEN230083 · SDE
Lumithera, Inc.
Ophthalmic · 326d
Not Cleared Oct 30, 2024
Stone Clear (SC-LP9-01)
DEN230082 · QNA
Sonomotion, Inc.
Gastroenterology & Urology · 328d
Not Cleared Oct 25, 2024
Dexter L6 System
DEN230084 · SDD
Distalmotion SA
General & Plastic Surgery · 315d
Not Cleared Oct 16, 2024
AMStent® Tracheobronchial Covered Stent System
DEN230087 · SDB
Peytant Solutions, Inc.
Anesthesiology · 301d
Not Cleared Oct 11, 2024
Versius Surgical System
DEN230078 · SCV
Cmr Surgical Limited
General & Plastic Surgery · 325d
Not Cleared Oct 08, 2024
Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection...
DEN230076 · QXY
Omron Healthcare, Inc.
Cardiovascular · 330d
Not Cleared Oct 07, 2024
Healgen Rapid Check COVID-19/Flu A&B Antigen Test
DEN240029 · SCA
Healgen
Microbiology · 122d
Not Cleared Sep 30, 2024
OcuCool
DEN230011 · QZQ
Recensmedical, Inc.
Ophthalmic · 592d
Not Cleared Sep 27, 2024
ShortCut
DEN240017 · SCZ
Pi-Cardia, Ltd.
Cardiovascular · 163d
Not Cleared Sep 12, 2024
Hearing Aid Feature (HAF)
DEN230081 · SCR
Apple, Inc.
Ear, Nose, Throat · 283d
Not Cleared Aug 28, 2024
Chronos®
DEN230067 · SCS
Germitec
General Hospital · 335d
Not Cleared Aug 16, 2024
First To Know Syphilis Test
DEN230090 · SBZ
Nowdiagnostics
Microbiology · 233d
Not Cleared Aug 12, 2024
SoClean 3+ Bacterial Reduction Device
DEN210037 · QXQ
Soclean, Inc.
General Hospital · 1062d
Not Cleared Aug 01, 2024
PGDx elio plasma focus Dx
DEN230046 · SBY
Personal Genome Diagnostics, Inc.
Pathology · 398d
Not Cleared Jul 16, 2024
allay Nerve Cap
DEN230061 · SBG
Tulavi Therapeutics
Neurology · 308d
Not Cleared Jul 15, 2024
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa...
DEN230092 · SBT
Diasorin Molecular, LLC
Microbiology · 200d
Not Cleared Jul 12, 2024
Terragene Bionova Photon Biological Indicator (BT225)
DEN220042 · QVB
Terragene S.A.
General Hospital · 742d
Not Cleared Jul 02, 2024
MagDI System
DEN240013 · SAH
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 98d