12 results · 41ms · Sources: EU EUDAMED, US FDA

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Spiration® Valve System

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·IMAGECHECKER D

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Gevia Deep Brain Stimulation (DBS) System

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·EMDOGAIN GEL

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Cord Stimulatort (SCS) System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM ULTRA XC INJECTABLE GEL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ICD Inogen VR, ICD Dynagen VR, ICD Dynagen DR, Momentum EL ICD VR, Momentum EL ICD DR, Vigilant EL ICD VR, Vigilant EL I

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·IGOTIS 5 HF-T (DF-4), 7 HF-T (DF-4, LI); IFORIA 7 HF-T (DF4, GB) IIESTO 5 HF-TIESTO 5 HF-T (DF-4)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·llesto 7 VT-T / 5 VR-T , 7 VR-T DX; Ifora 7 VR-T /5 VR-T /7 VR-T DX , 5 VR-T DX ; Itrevia 7 VT-T/ DX (GBLi), Intica 5 VR