510(k) Device Clearances

ActiGraph LEAP activity monitor (ActiGraph LEAP)

Actigraph, LLC

PET VCAR

GE Medical Systems SCS

VenAir, Sequential Compression System

Apex Medical Corp.

Quantum Mitohormesis (QMT) (M2101)

Quantumtx Pte. , Ltd.

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)

Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

Motilitycount Aps

Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable

CathRx, Ltd.

WallFlex Biliary PLUS RX Stent System

Boston Scientific

Bone Cement-Normal Viscosity

Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda

CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set

Cerenovus, Inc.

Heel Stick Safety Lancet (HHZ-II, HHZ-III)

Tianjin Huahong Technology Co., Ltd.

FlexCath Cross Transseptal Solution

Acutus Medical, Inc.

Instrument Case

Cochlear Americas

EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic

Boston Scientific Corporation

Sterile and Non-Sterile Ultrasound Gels

Jianerkang Medical Co., Ltd.

Nitrile Examination Gloves (Powder free, Blue)

Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)

Hardy Diagnostics

AxTiHA® Stand-Alone ALIF System

Innovasis

Logical Liner; World Liner; World Knee Patella

Signature Orthopaedics Pty, Ltd.

SoloSmart Injection Pen Adapter (SoloSmart®)

Biocorp Production

MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer

Mentor Worldwide, LLC

LCD Monitor (C1216W, C822W, C821W)

Shenzhen Beacon Display Technology Co., Ltd.

AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)

Poskom Co., Ltd.

ZSmile System

Dror Orthodesign , Ltd.

Creo Electrosurgical System with NP1 Instrument

Creo Medical, Ltd.

Mako Total Knee Application

Mako Surgical Corp.

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

Hologic, Inc.

Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves

Kl-Kepong Rubber Products Sdn. Bhd.

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes

Jiangsu Bonss Medical Technology Co., Ltd.

UltraCor™ Twirl™ Breast Tissue Marker

Bard Peripheral Vascular, Inc.