BEUDAMED
    70 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·Avant CDHFA700Q, CDHFA700T; Neutrino NxT CDHFA800Q, CDHFA800T, CDHFA600Q, CDHFA600T; Gallant CDHFA500Q, CDHFA500T; Entra

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Avant CDVRA700Q, CDVRA700T Neutrino NxT CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T, Gallant CDVRA500Q, CDVRA500T Entrant

    Implant, Dermal, For Aesthetic Use In The Hands

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane Lyft with Lidocaine

    Implant, Dermal, For Aesthetic Use In The Hands

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

    Immunohistochemistry Assay, Antibody, Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·Ki-67 IHC pharmDx

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·4Kscore Test

    Immunohistochemistry Assay, Antibody, Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

    Immunohistochemistry Assay, Antibody, Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A),HeartStart HS1 SMART Pads, Adult (M5071

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart OnSite Defibrillator and HeartStart Home Defibrillator

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart OnSite Defibrillator and HeartStart Home Defibrillator

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator (861304)