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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
913–936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2026
STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device...
K253572 · GAW
Ethicon, Inc.
General & Plastic Surgery · 130d
Cleared Mar 27, 2026
Synergy Disc Instruments
K253392 · QLQ
Synergy Spine Solutions, Inc.
Orthopedic · 178d
Cleared Mar 27, 2026
Electric wheelchair
K253307 · ITI
Foshan Dahao Medical Technology Co.,...
Physical Medicine · 179d
Cleared Mar 27, 2026
Contour ProtégéAI+
K253270 · QKB
Mim Software, Inc.
Radiology · 179d
Cleared Mar 27, 2026
ExaStim® Stimulation System (EXA-001)
K252893 · SDO
Aneuvo
Physical Medicine · 197d
Cleared Mar 27, 2026
Ryurei
K252295 · LOX
Terumo Corporation
Cardiovascular · 247d
Cleared Mar 27, 2026
ARTICOR planner
K252195 · LLZ
Artiness S.R.L
Radiology · 256d
Cleared Mar 27, 2026
Butterfly Gestational Age Tool
K252148 · IYN
Butterfly Network, Inc.
Radiology · 261d
Cleared Mar 27, 2026
SportLinc Syndesmosis Device
K252081 · HTN
Lincotek Medical
Orthopedic · 268d
Cleared Mar 27, 2026
MedCAD® AccuStride™ System
K252064 · PBF
Medcad
Orthopedic · 269d
Cleared Mar 27, 2026
OTTO™ Disinfecting Cap
K252006 · QBP
Icu Medical, Inc.
General Hospital · 273d
Cleared Mar 27, 2026
Asurys Fluid Management System
K251273 · HIG
Boston Scientific Corporation
Obstetrics & Gynecology · 337d
Cleared Mar 26, 2026
Multiflex Steerable Sheath 17.5F
K260626 · DYB
Vizaramed, Inc.
Cardiovascular · 28d
Cleared Mar 26, 2026
REAL INTELLIGENCE™ CORI™
K260601 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 30d
Cleared Mar 26, 2026
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
K260281 · LON
BIOMERIEUX
Microbiology · 56d
Cleared Mar 26, 2026
Automatic Electronic Blood Pressure Monitor (U90B series models including (...
K260273 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 56d
Cleared Mar 26, 2026
Lunit INSIGHT DBT (V1.2)
K253796 · QDQ
Lunit, Inc.
Radiology · 118d
Cleared Mar 26, 2026
SwiftMR
K253775 · QIH
Airs Medical, Inc.
Radiology · 120d
Cleared Mar 26, 2026
Surgify Halo (54.085.SHD.U1)
K253627 · HBE
Surgify Medical OY
Neurology · 127d
Cleared Mar 26, 2026
DeVilbiss 5 Liter Oxygen Concentrator (555)
K253549 · CAW
Devilbiss Healthcare, LLC
Anesthesiology · 132d
Cleared Mar 26, 2026
Stealth AXiS Cranial clinical application
K253379 · HAW
Medtronic Navigation, Inc.
Neurology · 177d
Cleared Mar 26, 2026
Robotic Surgical Instruments - Permanent Cautery Hook (470183)
K252926 · QSM
Restore Robotics
General & Plastic Surgery · 192d
Cleared Mar 25, 2026
Vortex5 Tailor's Bunion Correction System
K260291 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 55d
Cleared Mar 25, 2026
Airlock® Ankle Plating System
K260274 · HRS
Novastep SAS
Orthopedic · 55d