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: 2026–2026 ×
1,642 results
937–960 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Mar 25, 2026
Easydrip Classic Pen Needle
K252908 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 194d
Cleared Mar 25, 2026
Flex-Z™ Cervical Cage
K252432 · ODP
Spinepoint, LLC
Orthopedic · 236d
Cleared Mar 25, 2026
Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455,...
K252052 · HQC
Bausch and Lomb, Incorporated
Ophthalmic · 267d
Cleared Mar 25, 2026
CUVIS-joint (CJ150)
K252037 · OLO
Curexo, Inc.
Orthopedic · 268d
Cleared Mar 25, 2026
MiraChlor Antimicrobial Wound Solution
K252023 · FRO
Letus Corporation
General & Plastic Surgery · 268d
Cleared Mar 24, 2026
FebriDx Bacterial/Non-bacterial Assay
K260787 · QXA
Lumos Diagnostics, Inc.
Microbiology · 14d
Cleared Mar 24, 2026
LOGIQ Vita
K260673 · IYN
GE Medical Systems Ultrasound and...
Radiology · 22d
Cleared Mar 24, 2026
Senographe Pristina
K260087 · MUE
GE Medical Systems SCS
Radiology · 71d
Cleared Mar 24, 2026
LOQTEQ® VA Proximal Humerus Plate 3.5
K254253 · HRS
Aap Implantate AG
Orthopedic · 85d
Cleared Mar 24, 2026
Electric Wheelchair (E201)
K254012 · ITI
Nanjing CareMoving Rehabilitation...
Physical Medicine · 99d