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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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