BEUDAMED
    115 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay

    System, Oxygen, Aqueous

    FDA Pre-Market Approval
    FDA Class 3 ·TherOx® DownStream® Cartridge (DSC-2)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

    System, Oxygen, Aqueous

    FDA Pre-Market Approval
    FDA Class 3 ·TherOx Downstream System

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·Cerene Cryotherapy Device

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

    Analyzer, Data, Obstetric

    FDA Pre-Market Approval
    FDA Class 3 ·STAN S31 FETAL HEART MONITOR

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·ADEZA FETAL FIBRONECTIN EIK

    Device, Intrauterine, Contraceptive And Introducer

    FDA classification
    FDA Class 3 ·Device, Intrauterine, Contraceptive And Introducer

    System, Balloon, Intra-Aortic And Control, Reprocessed

    FDA classification
    FDA Class 3 ·System, Balloon, Intra-Aortic And Control, Reprocessed

    Apparatus, Electronanesthesia

    FDA classification
    FDA Class 3 ·Apparatus, Electronanesthesia

    Prosthesis, Hip, Constrained, Metal

    FDA classification
    FDA Class 3 ·Prosthesis, Hip, Constrained, Metal

    Metal Cemented Constrained Femorotibial Knee Prosthesis

    FDA classification
    FDA Class 3 ·Metal Cemented Constrained Femorotibial Knee Prosthesis

    Microsphere, Trace

    FDA classification
    FDA Class 3 ·Microsphere, Trace

    Band, Tubal Occlusion

    FDA classification
    FDA Class 3 ·Band, Tubal Occlusion

    Pacemaker, Bladder

    FDA classification
    FDA Class 3 ·Pacemaker, Bladder

    Kit, Balloon Repair, Catheter

    FDA classification
    FDA Class 3 ·Kit, Balloon Repair, Catheter

    Transcervical Contraceptive Tubal Occlusion Device

    FDA classification
    FDA Class 3 ·Transcervical Contraceptive Tubal Occlusion Device

    Stimulator, Carotid Sinus Nerve

    FDA classification
    FDA Class 3 ·Stimulator, Carotid Sinus Nerve