2,229 results · 19ms · Sources: EU EUDAMED, US FDA

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LifePulse High Frequency Ventilator

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·HFV STAR

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·HFV STAR

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LifePulse High Frequency Ventilator

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE (VAD)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·EPIC HF V-338

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·HFV INFANT STAR VENTILATOR

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD FOCALPOINT SLIDE PROFILER

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·HFV STAR (NEW MANUFACTURING SITE)

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LifePulse High Frequency Ventilator

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LifePulse High Frequency Ventilator

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Family of 1-piece IOLs packaged in the Daisy Wheel Configuration

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·T-SCAN 2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·TS2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·TRANSCAN T-SCAN 2000

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD FOCALPOINT GS IMAGING SYSTEM

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini System

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·Fluency® Plus Endovascular Stent Graft