510(k) Device Clearances

10F Sheath and Dilator Set

Argon Medical Devices, Inc.

MammoScreen BD

Therapixel

XeliteMed SuperM-Fix Spinal Bone Cement

Xelite Biomed , Ltd.

The Acumed Wrist Fixation System

Acumed, LLC

BIOCHARGE

Nanofiber Solutions, LLC

SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove

Showa Best Glove, Inc.

Sysmex XR-Series (XR-20) Automated Hematology Analyzer

Sysmex America, Inc.

Co2 Laser System, Models: PureLase And VanLase

Cpmt Laser (Canadian Pioneer Medical Technology Corporation)

Vinyl Examination Gloves(Yellow)

Liuping Trading Co., Ltd.

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

Ambu A/S

Versalock Mini and Micro Plating System

GM Dos Reis Industria e Comercio Ltda.

JiveX (Model Number / Release: 5.4)

Visus Health IT GmbH

SpotLight/SpotLight Duo (with DLIR option)

Arineta , Ltd.

NeuroBlate System

Monteris Medical

RS85 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

TriSalus TriGuideTM Guiding Catheter

Trisalus Life Sciences

Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))

Medline Industries, LP

Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and

Donnevie Medical Technology (Shanghai) Co. , Ltd.

Panther 5

Origin Medical Devices

Medical Diode Laser (M2)

Wuhan Pioon Technology Co., Ltd.

Kyphoplasty Balloon Dilatation Catheters

Shanghai Lange Medtech Co., Ltd.

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, an

Sri Trang Gloves (Thailand) Public Company Limited

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B,

Zhuzhou Goldenhot Medical Technology Co., Ltd.

Back 3 COLOR

Swims America Corp

VioSeal

Spident Co., Ltd.

Overture Orthopaedics Patellofemoral System

Overture Resurfacing, Inc.

VELO Respiratory Test

Lex Diagnostics Limited

Harvest Conceal ZR Block Out

Harvest Dental Products, LLC

Novum IQ Syringe Pump (40800BAXUS)

Baxter Healthcare Corporation

Focus HD 43 Detector

Iray Technology Taicang , Ltd.