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
aboNT SYRINGE
Nipro Medical Corporation
Care Team Portal
Vivify Health, Inc.
SIRIUS Endoscope System (PR-SI-1230)
Precision Robotics (Hong Kong) Limited
R3ACT Stabilization System
Paragon 28, Inc.
ROSA® Shoulder System
Orthosoft Inc. (d/b/a) Zimmer CAS
Fresenius Liberty Select Cycler
Fresenius Medical Care Renal Therapies Group, LLC
Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
Canadian Pioneer Medical Technology Corporation (Cpmt Laser)
Introducer Sheath Kits
Beijing Demax Medical Technology Co.,Ltd
IPL Home Use Hair Removal Device
Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.
SuperBall-RC
Arcuro Medical , Ltd.
pREBOA-PRO Catheter
Prytime Medical Devices, Inc.
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
Contec Medical Systems Co.,Ltd
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
Contec Medical Systems Co.,Ltd
FAQ (LED Panel); FAQ (Dual LED Panel)
Foreo, Inc.
MyoCycle MC-2 (Home / Home + / Pro / Pro +)
Myolyn, LLC
Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
Inova Diagnostics, Inc.
Kneevoice Cartilage Evaluation System (750-3600-001)
Kneevoice, Inc.
Sure-Fine Insulin Syringes
Shina Med Corporation
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator wi
Medtronic Perfusion Systems
RefleXion Medical Radiotherapy System, Reflexion X2
Reflexion Medical, Inc.
DiversiVy Facet Screw System
Vy Spine, LLC
Access BR Monitor
Beckman Coulter, Inc.
BioSphere Putty; BioSphere MIS Putty
Synergy Biomedical
Biotech Dental Kits
Biotech Dental, Sas
ClotTriever BOLD Catheter
Inari Medical, Inc.
Eclipse MINI Model 98900
Spacelabs Healthcare, Ltd.
FaSet Fixation System
Dio Medical Corporation
Aqua Naina Plus Sterile Saline Solution
Chemtex USA, Inc.
KIDS Arterial Filters
Sorin Group Italia S.R.L.
Vital Signs Monitors
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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