510(k) Device Clearances

K-ASSAY CRP (Ver.2)

Kamiya Biomedical Company, LLC

MiroCam® Capsule Endoscope System

Intromedic Co., Ltd.

ARDO Alyssa

Ardo Medical AG

Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

Shenzhen Siken 3D Technology Development Co., Ltd.

Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable

Fresenius Kabi AG

Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 113

Baisheng Medical Co., Ltd.

HandX™ Monopolar Scissors

Human Xtensions , Ltd.

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

Brainlab AG

Infinity CentralStation Wide, Infinity M300, Infinity M300+

Draeger Medical Systems, Inc.

Disposable Sterilized Latex Surgical Gloves

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

LF900

Daesung Maref Co., Ltd.

Promisemed Fine Biopsy Needle

Promisemed Hangzhou Meditech Co., Ltd.

APEX 6

Rf Innovations, Inc.

Armada™ 14 NC PTA Catheter

ABBOTT MEDICAL

Mpact 3D Metal Augments II

Medacta International S.A.

PMT Facet Fixation System, Lumbar (PMT FFS-LX)

Providence Medical Technology, Inc.

AlignerFlow LC

Voco GmbH

TULSA-PRO System

Profound Medical, Inc.

Jmoon Conductive Gel

Shenzhen Ulike Smart Electronics Co., Ltd.

Levator Elite (Model LE9011)

Shenzhen Dongdixin Technology Co., Ltd.

PRAEVAorta®2

Nurea

Clarius Ejection Fraction AI

Clarius Mobile Health Corp.

LoFric Elle Pro

Wellspect AB

Pterygoid Indication for GM Helix Implants

JJGC Indústria e Comércio de Materiais Dentários S.A.

Dental Cone; Dental Sponge

Medizin Produkte Neustadt GmbH (Mpn)

Drive Rail System

OrthoPediatrics Corp.

Disposable Medical Face Mask

Hubei Mediunion Medical Products Co., Ltd.

ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Sten

Coloplast Corp.

Portare System (FA-001)

Grumpy Innovation, Inc.

Esperance Distal Access Catheter

Wallaby Medical