510(k) Device Clearances

Neurophet AQUA

Neurophet., Inc.

Meduloc Intramedullary Fracture Fixation (IFF) System

Meduloc, LLC

BoneView

Gleamer

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System

Pentax of America, Inc.

Levina Pelvic Floor Muscle Stimulator (RS-48)

Zmi Electronics , Ltd.

ResQ Administration Set

Q For Plastic Industries

Prana System

Prana Surgical

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert

Encore Medical, L.P Dba Enovis

Lunit INSIGHT MMG

Lunit, Inc.

ivWatch Model 400

Ivwatch, LLC

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

Dk Medivision Co., Ltd.

eCARTv5 Clinical Deterioration Suite (“eCART”)

Agilemd, Inc.

ExacTrac Dynamic

Brainlab AG

iMap 3D Mapping & Navigation System (iMap System)

Cardionxt, Inc.

D²RS and D²RS 9090

Stephanix

IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)

Shenzhen Huachuangtong Industrial Co., Ltd.

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

Boston Scientific Corporation

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing

Diversatek Healthcare

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)

Zhejiang Lanhine Medical Products, Ltd.

HD-550 Video Endoscope System

Sonoscape Medical Corp.

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT

DiaSorin, Inc.

Stryker and Serf hip devices

Howmedica Osteonics Corp (Dba Stryker Orthopaedics)

NeuroStar Advanced Therapy System (Version 3.7)

Neuronetics

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Cove Strip

SeaSpine Orthopedics Corporation

Vydence Family of Lasers

Vydence Medical Industria E Commercio Ltda

Zone Specific AIM

Conmed Corporation

ACCLARENT AERA Eustachian Tube Dilation System

Acclarent, Inc.

Fiber Dust PRO

Quanta System Spa

Panther TPS

Prowess, Inc.