BEUDAMED
    479 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS); PROGEL Spare Tips accessory; PROGEL 6 Extended Tips accessory; PROGEL 11 Extende

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·MAXUM

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 630G System

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 670G System

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ; EZ Steer Non-Navigational 4mm (TC) & (THR) ; Celsius 4mm Bi-Dir T ;

    Fluid, Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·PERFLUORON OCULAR ENDOTAMPONADE

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·THIN PREP PROCESSORS

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·HiResolution Bionic Ear System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·UV-PMMA PCL'S

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·Model 203 Life Pulse High Frequency Ventilator

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL PLEURAL LEAK SEALANT

    Device, Cystometric, Air

    FDA classification
    FDA Class 3 ·Device, Cystometric, Air

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RESTYLANE INJECTABLE GEL

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

    Biologic Material, Dental

    FDA Pre-Market Approval
    FDA Class 3 ·Straumann Emdogain

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006)

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Percept™ PC INS with BrainSense™ (Model B35200)