54 results · 21ms · Sources: EU EUDAMED, US FDA

Electrical Impedance Spectrometer

FDA Pre-Market Approval
FDA Class 3 ·Nevisense

Electrical Impedance Spectrometer

FDA Pre-Market Approval
FDA Class 3 ·NEVISENSE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·STRKYER KNEE AUGMENTATION GRAFT

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S)

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·CONTIGEN BARD COLLAGEN IMPLANT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Accessory Medical Adhesive, Accessory Mineral Oil, Accessory Vein Pick, Accessory Kit Lead Cap, Accessory Stylet TAPER 0

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer IITM XP Cardiac RF Ablation System (also branded as Blazer II Prime XP, IntellaTip MiFi XP, IntellaTip MiFi OI, I

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus

CARDIAC ELECTRODE

FDA 510(k)
FDA Class 3 ·Cardiovascular

Hiv Self-Tests

FDA classification
FDA Class 3 ·Hiv Self-Tests

Monitor,Test,Hiv-1

FDA classification
FDA Class 3 ·Monitor,Test,Hiv-1

Kit, Sample Collection, Hiv

FDA classification
FDA Class 3 ·Kit, Sample Collection, Hiv

Kit, Test, Saliva, Hiv-1&2

FDA classification
FDA Class 3 ·Kit, Test, Saliva, Hiv-1&2

System, Test, Home, Hiv-1

FDA classification
FDA Class 3 ·System, Test, Home, Hiv-1