12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5
FDA 510(k)
FDA Class 3
·Cardiovascular
Valve, Pulmonary
FDA Pre-Market Approval
FDA Class 3
·Spiration® Valve System
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
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA classification
FDA Class 3
·Stimulator, Electrical, Implanted, For Parkinsonian Symptoms