BEUDAMED
    2,328 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·VARIOUS MODELS OF ICD'S

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·VARIOUS MODELS OF PACEMAKERS ICS 3000/ EPR 1000 PLUS

    Pump, Drug Administration, Closed Loop

    FDA Pre-Market Approval
    FDA Class 3 ·GENESA(R) SYSTEM

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Alternative Active Anchor (part number 104504)

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Vercise Genus Deep Brain Stimulation System

    Catheter, Percutaneous, Long Term, Intraspinal

    FDA Pre-Market Approval
    FDA Class 3 ·PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF IQ RESTOR IOLS +3.0 D

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACS: CENTAUR AFP IMMUNOASSAY

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION SYSTEM

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·ENLITE SENSOR

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·SOF SENSOR

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·DRIVER MX2 CORONARY STENT SYSTEM

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·Raindrop Near Vision Inlay

    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, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·ORTHOPAK II BONE GROWTH STIMULATOR