Search FDA 510(k) Devices

5,352 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
25–48 of 174,061
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
Cleared Mar 25, 2026
Arterial Pressure Monitoring Set/Tray
K254278 · DQO
Spectrum Vascular
Cardiovascular · 85d
Cleared Mar 25, 2026
LYNX COBLATION Laryngeal Wand (72290254)
K253680 · GEI
ArthroCare Corporation
General & Plastic Surgery · 124d
Cleared Mar 25, 2026
Invictus Bands System
K253615 · OWI
Alphatec Spine, Inc.
Orthopedic · 127d
Cleared Mar 25, 2026
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
K253406 · LHN
Mevion Medical Systems, Inc.
Radiology · 176d
Cleared Mar 25, 2026
Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with...
K253322 · BZE
Medline Industries, LP
Anesthesiology · 176d
Cleared Mar 25, 2026
Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A...
K253184 · EOB
Zhuhai Wesee Meditech Co., Ltd.
Ear, Nose, Throat · 180d