510(k) Device Clearances

HJY VisualNext 3D Endoscopic Vision System

Hjy Smart Medical Device Co., Ltd.

Powder free nitrile examination glove- blue, non-sterile

Hong Seng Gloves Sdn Bhd

Noris Medical Dental Implants System - Cortical

Noris Medical , Ltd.

Medical Monitor (27HS714S)

Lg Electronics.Inc

Tandem Mobi insulin pump with interoperable technology

Tandem Diabetes Care, Inc.

Next Generation 088 Catheter

Balt USA, LLC

Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Ser

Unimed Medical Supplies, Inc.

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)

Orthocon, Inc.

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System

Canary Medical USA, LLC

Powder Free Nitrile Examination Glove, Non-sterile (Blue)

Ksg Medicare Sdn. Bhd.

Amplatzer Talisman Delivery Sheath

ABBOTT MEDICAL

Montblanc Plate System

Medifield Medical Co., Ltd.

Electronic Blood Pressure Monitor

Dongguan Kangweile Electronic Technology Co., Ltd.

Strauss Surgical cystoscope, hysteroscope and accessories Instruments

American Medical Endoscopy, Inc.

iQ200 Series

Beckman Coulter, Inc.

LUNE™ PureHygiene

Enamel Pure

Hypnos (369054-200)

Cadwell Industries, Inc.

Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System

Canon Medical Systems Corporation

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V

Remex Medical Corporation

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit

Bd

CVAC Aspiration System

Calyxo, Inc.

LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)

Dongguan Yijiaming Technology Co., Ltd.

OptiMap™ System

Boston Scientific Corporation

Intelligence LaserComb

Yibin Yingtong Intelligent Technology Co., Ltd.

Dukal SMS Sterilization Wrap

Dukal, LLC

Zionic Pro Max (Radiofrequency)

Termosalud S.L.

BrainView QEEG Software

Medeia, Inc.

VELMENI for DENTISTS (V4D)

Velmeni, Inc.

RxSight Insertion Device

Rxsight, Inc.