Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA classification

FDA Class 3 ·Prosthesis, Ankle, Uncemented, Non-Constrained

Fixture Mount Kit

FDA classification

FDA Class 1 ·Fixture Mount Kit

Internacional Ventur S.A.

Importer

🇪🇸 Spain·23 Manufacturers

Pierced Ear/Entry Cleaning Tray

FDA classification

FDA Class 1 ·Pierced Ear/Entry Cleaning Tray

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Stimulator, Intramuscular, Automatic

FDA classification

FDA Class 2 ·Stimulator, Intramuscular, Automatic

General Purpose Reagent

FDA classification

FDA Class 1 ·General Purpose Reagent

First Aid Kit With Drug

FDA classification

FDA Not Classified ·First Aid Kit With Drug

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification

FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification

FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

FDA classification

FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

Temporary Carotid Catheter For Embolic Capture

FDA classification

FDA Class 2 ·Temporary Carotid Catheter For Embolic Capture

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System

Prostate Seeding Kit

FDA classification

FDA Class 2 ·Prostate Seeding Kit

Radiology Dental Tray

FDA classification

FDA Class 2 ·Radiology Dental Tray

Discography Kit

FDA classification

FDA Class 2 ·Discography Kit

Mri Disposable Kit

FDA classification

FDA Class 2 ·Mri Disposable Kit

Radiographic Contrast Tray

FDA classification

FDA Class 2 ·Radiographic Contrast Tray

Biopsy Needle Guide Kit

FDA classification

FDA Class 2 ·Biopsy Needle Guide Kit