510(k) Device Clearances

Protective Cap

Neobiotech Co., Ltd.

Denture Base

Riton 3D Technology Co., Ltd.

HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Sof

Hoya Lamphun , Ltd.

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

Vuno, Inc.

Precision AI Surgical Planning System (PAI-SPS)

Precision AI Pty, Ltd.

CoraForce Microcatheter, CoraFlex Microcatheter

Reflow Medical, Inc.

HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked c

Access Vascular, Inc.

Magnifico Open (100009900); Magnifico MSK ( 100009910)

Esaote, S.p.A.

SABA Tampons

Essity Higiene Y Salud Mexico. S.A. DE C.V.

MediLab

Sigma Scientific Services, LLC

VASSALLO GT 018 G12; VASSALLO GT 018 G30

Filmec Co. , Ltd.

Inspan ScrewLES Fusion System

Lespine Innovations, LLC

LungTrainer (MD2 & MD3)

Lung Trainers, LLC

Digital Radiography System (ManntiX B, ManntiX K)

Shenzhen Browiner Tech Co., Ltd.

ArtiSential Trocar

Livsmed, Inc.

Chocolate PTA Balloon Catheter

Medtronic, Inc.

Access Thyroglobulin

Beckman Coulter, Inc.

ANDI 2.0

Imeka Solutions, Inc.

Light-curing Coloring Materials (ALCM)

Aidite (Qinhuangdao) Technology Co., Ltd.

TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)

Megin OY

Infrared Thermometer

Alicn Medical Shenzhen, Inc.

Liberant Thrombectomy System

Medtronic, Ireland

reepot Nd; YAG laser system

Ilooda Co,., Ltd.

multiFlux 1000 (F00012408)

Fresenius Medical Care Renal Therapies Group, LLC

Sober Self-Test

Sober Ip, LLC

TriMed Posterior Malleolus Fixation System

TriMed, Inc.

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets

Hemodia Sas

b-ONE MOBIO Total Knee System

B-One Ortho, Corp.

POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens

INTEROJO, Inc.

1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)

Zhengzhou PZ Laser Slim Technology Co., Ltd.