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
49–72 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
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