510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
Cocoon Convective Warming System, Model CWS7000
Care Essentials Pty, Ltd.
Wrist Blood Pressure Monitor
Zhuhai Yueja Medical Device Technology Co., Ltd.
Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (
Stryker Sustainability Solutions
Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs
Shandong Blue Sail Health Technology Co., Ltd.
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
VivaQuant, Inc.
Sterilization Pouches and Reels
Shanghai Jianzhong Medical Packaging Co., Ltd.
Stingray LP Catheter
Boston Scientific
MyPAO Guides
Medacta International S.A.
Electrical Scooter, WT-T4SU
W'U'S Tech Co., Ltd.
Oxygen Concentrator, Model JAY-5AW
Longfian Scitech Co., Ltd.
Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
Guangdong Golden Leaves Technology Development Co., Ltd.
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Co
Dentsply Sirona, Inc.
IMRIS iMRI 3T V
Deerfield Imaging, Inc.
ExcelsiusFlex
Globus Medical, Inc.
BodySculp
Rohrer Aesthetics, LLC
Personalized Therapy Comfort Settings (PTCS)
Resmed Corp
TRUDERMAL Pro (ZLD-390)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
MTM301 Blood Glucose and Ketone Monitoring System
Apex BioTechnology Corp.
myAir
Resmed Corp
Gastric Alimetry
Alimetry , Ltd.
Teal Wand
Teal Health, Inc.
Gemini 2 810+980 Soft Tissue Laser
Azena Medical, LLC
Catapult Guide Sheath
Contract Medical International, GmbH
Play and Joy Water-Based Lubricant
Innovemed Bio-Tech Co., Ltd.
TransForm McCarthy Mitral Annuloplasty Ring (TF)
Genesee Biomedical, Inc.
LOQTEQ® VA Elbow Plates 2.7/3.5 System
Aap Implantate AG
Stealth AXiS ENT clinical application
Medtronic Navigation, Inc.
Refobacin Bone Cement R (110034355)
Biomet France
Freedom® Total Knee System Titanium Tibial Base Plate
Maxx Orthopedics, Inc.
Dura-Crown
Hangzhou SHINING3D Dental Technology Co., Ltd.
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