510(k) Device Clearances

Pen Needle

Hh Global Technology, Inc.

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2

Ambu A/S

Led Mask Platinum Md

Cellreturn Co., Ltd.

Vigilant Software Suite – Vigilant Master Med

Fresenius Kabi AG

UroLift 2 ATC Advanced Tissue Control System

Neotract, Inc.

Intense Pulse Light Therapeutic Apparatus

Shenzhen Greatro Electronic Technology Co., Ltd.

PosiSep X BAM Hemostat Dressing/Intranasal Splint

Hemostasis, LLC

da Vinci Surgical System (IS5000)

Intuitive Surgical, Inc.

IPL Hair Removal

Shenzhen Qiaochengli Technology Co., Ltd.

Aptima Trichomonas vaginalis Assay

Hologic, Inc.

FORMA Composite (Shade A3D)

Ultradent Products, Inc.

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

Stryker GmbH

lntravascular Administration Sets with Stopcock and Manifold

Baxter Healthcare Corporation

Mariana Minerva; Mariana Nimbus

Resmed Pty , Ltd.

Medical Face Mask

Haian Medigauze Co., Ltd.

Rapid RV/LV

Ischemaview, Inc.

Wellead Endoscopic Seal

Well Lead Medical Co., Ltd.

Disposable Polymer Ligation Clips

Hangzhou Kangji Medical Instrument Co., Ltd.

Merge Universal Viewer (MUV)

Merge Healthcare Incorporated

Plastic Surgical Kits

Dentsply Sirona, Inc.

Biowy Tym Tube (TT)

Biowy Corporation

Endoform Dermal Template

Aroa Biosurgery , Ltd.

Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application

Avation Medical, Inc.

IPL Hair Removal Device (BE965A, BE965B, BE965C)

Shenzhen Yang WO Electronic Co., Ltd.

Microwave Ablation Device

Nanjing Dewen Medical Technology Co., Ltd.

0.014” Willow Guidewire

Arbor Endovascular, LLC

eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)

Anker Innovations Limited

Well-Life Incontinence Stimulation System (WL-2405i(P))

Well-Life Healthcare , Ltd.

Dermablate

Asclepion Laser Technologies GmbH

HyperFlex™ Bunion Correction System

Footbridge Medical