510(k) Device Clearances

Co-Ablation System with Sterile Co-Ablation Probe

Hygea Medical Technology Co., Ltd.

ScioCardio ECG Analysis Platform

Synergen Technology Labs, LLC

Hand-held IPL device(JOVS Graphene Hair Removal Device)

Shenzhen Qianyu Technology Co., Ltd.

Mosaic (V1.0.1)

Navier Medical

SCENARIA View

Fujifilm Healthcare Corporation

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

Canon Medical Systems Corporation

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG

Radisen Co., Ltd.

SparkTM Clear Aligner System

Ormco Corporation

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

Abbott Laboratories

Velmeni for Dentists (V4D) Endo-Perio

Velmeni, Inc.

Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 3

Boston Scientific Corporation

Senhance Surgical System

Asensus Surgical, Inc.

ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH

Livsmed, Inc.

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)

Abbott

FreeStyle Comfort (AS200 / FreeStyle Comfort)

Caire, Inc.

BreatheBand® (Model 1000)

Exemplar Medical, LLC

AtriCure cryoICE BOX (ACM)

AtriCure, Inc.

Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)

Hunan Ceramaster Material Technology Co., Ltd.

Bronchoscope System

Shanghai AnQing Medical Instrument Co., Ltd.

CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System

Ascensia Diabetes Care U.S., Inc.

AccuCTP

ArteryFlow Technology Co., Ltd.

EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil

Covidien

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP

Unimax Medical Products Co., Ltd.

EchoGo Heart Failure (2.0)

Ultromics Limited

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control

Stryker Endoscopy

EQUIA LC ONE

GC America, Inc.

Medline Universal Grounding Pad

Medline Industries, Inc.

Monarch Platform, Urology

Auris Health, Inc.

uDR 780i

Shanghai United Imaging Healthcare Co., Ltd.

SnugFit ASA Extension

Medacta International S.A.