Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationFocus CDx BRCA HRD

ICON (LR) Limited

Authorized representative

🇮🇪 Ireland·37 Manufacturers·384 Devices

Ultrasound Bronchoscope

FDA classification

FDA Class 2 ·Ultrasound Bronchoscope

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·4Kscore Test

FDA Pre-Market Approval

Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack

Additively Manufactured, Preformed, Resin Denture Tooth

FDA classification

FDA Class 2 ·Additively Manufactured, Preformed, Resin Denture Tooth

Medication Management System, Remote

FDA classification

FDA Class 2 ·Medication Management System, Remote

Hospital Continuous Glucose Monitoring System

FDA classification

FDA Class 2 ·Hospital Continuous Glucose Monitoring System

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·xT CDx

WERO GmbH & Co. KG

Importer

🇩🇪 Germany·9 Manufacturers

Bassinet, Hospital

FDA classification

FDA Class 2 ·Bassinet, Hospital

Orthana GmbH

Importer

🇩🇪 Germany·12 Manufacturers

PACEMAKER/EP DRAPE W/MICROBAN & DUAL FC POUCHES, 86" X 125"

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

Amplitude-Integrated Electroencephalograph

FDA classification

FDA Class 2 ·Amplitude-Integrated Electroencephalograph

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER

Aesthetic Group

Importer

🇫🇷 France·11 Manufacturers

Test, Propoxyphene, Over The Counter

FDA classification

FDA Class 2 ·Test, Propoxyphene, Over The Counter

Test For Periprosthetic Joint Infection

FDA classification

FDA Not Classified ·Test For Periprosthetic Joint Infection

Dna And Rna Oncology Controls

FDA classification

FDA Class 2 ·Dna And Rna Oncology Controls