BEUDAMED
    836 results · 29ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Oximeter, Fetal Pulse

    FDA Pre-Market Approval
    FDA Class 3 ·COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY

    Oximeter, Fetal Pulse

    FDA Pre-Market Approval
    FDA Class 3 ·COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR

    Oximeter, Fetal Pulse

    FDA Pre-Market Approval
    FDA Class 3 ·COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING

    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

    FDA Pre-Market Approval
    FDA Class 3 ·URO VYSION BLADDER CANCER KIT ASSAY

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RESTYLANE

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvéderm Injectable Gel Implants (Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive)

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane, Perlane, Restylane-L, Restylane Lyft with Lidocane and Restylane Silk Injectable Gels

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvederm Injectable Gel Implants, Juvederm Voluma XC, Juvederm Vollure XC, Juvederm Volbella XC

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

    Filler, Bone Void, Synthetic Peptide

    FDA Pre-Market Approval
    FDA Class 3 ·AUGMENT Bone Graft and AUGMENT Injectable

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Pulse Generator, Permanent Implantable, Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Ele

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate 2100/2100 VI System

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA classification
    FDA Class 3 ·Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·GELSYN-3

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM SHARE SYSTEM