Search FDA 510(k) Devices

5,369 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
361–384 of 174,061
Cleared Feb 20, 2026
SPRY TMS Therapy System (0550)
K251653 · OBP
Soterix Medical, Inc.
Neurology · 267d
Cleared Feb 19, 2026
TrueFit Bolus
K260308 · MUJ
Adaptiiv Medical Technologies, Inc.
Radiology · 20d
Cleared Feb 19, 2026
LacertaMatrix
K260218 · KGN
Lacerta Life Sciences
General & Plastic Surgery · 27d
Cleared Feb 19, 2026
AS Software Version Asera
K260205 · LLZ
AS Software, LLC
Radiology · 27d
Cleared Feb 19, 2026
AuST CSP Introducer
K260163 · DYB
CenterPoint Systems, LLC
Cardiovascular · 30d
Cleared Feb 19, 2026
Meniscus Versaflex
K254188 · GAT
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 58d
Cleared Feb 19, 2026
VERTICALE GPS Instruments
K254148 · OLO
Silony Medical GmbH
Orthopedic · 59d
Cleared Feb 19, 2026
Portable Dental X-ray Device (GT-1)
K254018 · EHD
Guilin Refine Medical Instrument Co.,...
Radiology · 66d
Cleared Feb 19, 2026
Access anti-HBc Total
K253687 · SEI
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Feb 19, 2026
Spine Guidance 5.4 Software
K253623 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 93d
Cleared Feb 19, 2026
Acclarent AERA Eustachian Tube Balloon Dilation System
K253612 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 93d
Cleared Feb 19, 2026
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
K253398 · FXX
Efofex, Inc.
General Hospital · 142d
Cleared Feb 19, 2026
Retrograde Coronary Sinus Perfusion Cannulae
K253203 · DWF
Medtronic, Inc.
Cardiovascular · 146d
Cleared Feb 19, 2026
SkinStylus SteriLock MicroSystem (MP1209SL)
K253002 · QAI
Esthetic Medical, Inc.
General & Plastic Surgery · 153d
Cleared Feb 19, 2026
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe
K252814 · QNQ
CMT Health PTE., Ltd.
General Hospital · 168d
Cleared Feb 19, 2026
ATLAS™ Expandable Osteotomy Wedge System
K252733 · PLF
MiRus, LLC
Orthopedic · 175d
Cleared Feb 19, 2026
Valence Robotic Navigation System
K252597 · OLO
Alphatec Spine, Inc.
Orthopedic · 188d
Cleared Feb 19, 2026
Monaco RTP System (6.3)
K252002 · MUJ
Elekta Solutions AB
Radiology · 237d
Cleared Feb 19, 2026
Erchonia DPN Laser (Model# EVRL)
K251903 · NHN
Erchonia Corporation
Physical Medicine · 244d
Cleared Feb 18, 2026
1688 4K Camera System with Advanced Imaging Modality
K260185 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 28d
Cleared Feb 18, 2026
Mobility Scooter (S3)
K253643 · INI
Shenzhen Zhimahuaerkai Technology...
Physical Medicine · 91d
Cleared Feb 18, 2026
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial...
K253637 · MBH
Howmedica Osteonics Corp., Dba...
Orthopedic · 91d
Cleared Feb 18, 2026
Alere NT-proBNP for Alinity i
K253539 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 97d
Cleared Feb 18, 2026
BTL-754FF
K252561 · GEX
BTL Industries, Inc.
General & Plastic Surgery · 189d