Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Open Irigation (OI) Ablation Catheter families: Blazer OI, IntellaTip MiFi OI, IntellaNav OI, and IntellaNav MiFi OI Abl

Human BCR-ABL Gene T315I Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)

Device

EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries

Micron Spoon Bobbin

FDA registration

MIDWEST STERILIZATION CORP.·1 product·🇺🇸 United States

LifeGlobal® Micropipet

FDA UDI

LIFEGLOBAL GROUP, LLC·00815965021867·LG µPipets®: Blastomere Biopsy, 35° - GREEN (1pc)

Kering Eyewear Spa

FDA registration

DELTA S.R.L.·1 product·🇮🇹 Italy

TRENTI INDUSTRIA OCCHIALI SpA

FDA registration

TRENTI INDUSTRIA OCCHIALI SpA·1 product·🇮🇹 Italy

TRENTI INDUSTRIA OCCHIALI SpA

FDA registration

TRENTI INDUSTRIA OCCHIALI SpA·1 product·🇮🇹 Italy

Kering Eyewear Spa

FDA registration

DELTA S.R.L.·1 product·🇮🇹 Italy

Valkyrie Thoracic Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Valkyrie Thoracic Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

ICT

FDA 510(k)

FDA Class 2 ·Radiology

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

FDA 510(k)

FDA Class 2 ·Radiology

HyPHo Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

FDA 510(k)

FDA Class 2 ·Neurology

IMRIS ONCOLOGY PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

LATEX PATIENT EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

PATIENT EXAMINATION GLOVES-ANATOMICAL GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE

FDA 510(k)

FDA Class 1 ·General Hospital