Search FDA 510(k) Devices

5,436 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1393–1416 of 174,061
Cleared Oct 16, 2025
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing
K252612 · QEW
Penumbra, Inc.
Cardiovascular · 58d
Cleared Oct 16, 2025
Viewer (5.4)
K252476 · LLZ
Brainlab AG
Radiology · 70d
Cleared Oct 16, 2025
Injector Force Max Single Use Injector (NM-400L)
K252247 · FBK
Olympus Medical Systems Corporation
Gastroenterology & Urology · 90d
Cleared Oct 16, 2025
Alpha Endo Handpiece (Alpha Endo)
K252223 · EKX
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Dental · 92d
Cleared Oct 16, 2025
FFX Facet Fixation System
K252153 · MRW
Sc Medica
Orthopedic · 99d
Cleared Oct 16, 2025
Light Therapy Mask (1019055)
K252093 · OHS
Merchsource, LLC
General & Plastic Surgery · 105d
Cleared Oct 16, 2025
NeurAxis IB-Stim (01-1020)
K252024 · QHH
Neuraxis
Gastroenterology & Urology · 108d
Cleared Oct 16, 2025
Arthrex Synergy Vision Imaging System
K251994 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 111d
Cleared Oct 16, 2025
Uterine Aspiration Set
K251882 · HHK
Gcmedica Enterprise Ltd.(Wuxi)
Obstetrics & Gynecology · 118d
Cleared Oct 16, 2025
Elos Accurate Hybrid Base
K251497 · NHA
Elos Medtech Pinol A/S
Dental · 154d
Cleared Oct 16, 2025
Coolfase
K250852 · GEI
Asterasys Co., Ltd.
General & Plastic Surgery · 209d
Cleared Oct 16, 2025
MateLaser Medical Diode Laser Systems (ML-DLS-30)
K250731 · NVK
Matelaser, Inc.
Dental · 219d
Cleared Oct 16, 2025
Re:Balans
K243727 · DSB
Mode Sensors AS
Cardiovascular · 317d
Cleared Oct 16, 2025
SurgiAid Collagen Wound Dressing (HA)
K242100 · KGN
Maxigen Biotech, Inc.
General & Plastic Surgery · 455d
Cleared Oct 15, 2025
TargetCool-e
K253348 · GEH
Recensmedical, Inc.
General & Plastic Surgery · 15d
Cleared Oct 15, 2025
BioBrace® Extra-Articular Ligament Augmentation Kit
K252946 · MAI
Conmed Corporation
Orthopedic · 30d
Cleared Oct 15, 2025
LOCATOR® Angled Abutment
K252944 · NHA
Zest Anchors, LLC
Dental · 30d
Cleared Oct 15, 2025
ELEOS™ Limb Salvage System with NanoCept® Technology
K252920 · QZZ
Onkos Surgical, Inc.
Orthopedic · 33d
Cleared Oct 15, 2025
InbellaMulti System
K252367 · GEI
Inbella Medical, Inc.
General & Plastic Surgery · 77d
Cleared Oct 15, 2025
AGFA HealthCare Enterprise Imaging
K252199 · LLZ
Agfa Healthcare N.V.
Radiology · 93d
Cleared Oct 15, 2025
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
K252020 · HRX
Hand Biomechanics Lab, Inc.
Orthopedic · 107d
Cleared Oct 15, 2025
syngo.CT Dual Energy
K251805 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Oct 15, 2025
Bonafix Implant Abutments
K251294 · NHA
Zentek Medical, LLC
Dental · 173d
Cleared Oct 15, 2025
Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature...
K250979 · NZE
Zoll Circulation, Inc.
Cardiovascular · 198d