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

    Tympanostomy Tube Delivery Product With Drug

    FDA Pre-Market Approval
    FDA Class 3 ·Tula SystemTube Delivery System (TDS)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3

    Automated External Defibrillators (Non-Wearable)

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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·AUTIMA/AURORA CARDIAC PACING SYSTEM

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Endurant Stent Grafyt System, Endurant II Stent Graft System, Ednurant II AUI Stent Graft System, Endurant IIs Stent Gra

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode

    Laparoscopic Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·DISPOSABLE FALOPE-RING BAND APPLICATOR KITS

    Laparoscopic Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·DISPOSABLE FALOPE-RING BANK APPLICATOR KITS

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·TCI HEARTMATE 1000A IP LVAS

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·CONTIGEN BARD COLLAGEN IMPLANT

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT

    Glue, Surgical, Arteries

    FDA Pre-Market Approval
    FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CARDIOMEMS

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOSTE(TM) BETA-CATH(TM) SYSTEM

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·BETA-CATH (TM) SYSTEM

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CardioMEMS Hospital System, model CM3100

    System, Laser, Transmyocardial Revascularization

    FDA Pre-Market Approval
    FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CardioMEMS HF System

    System, Identification, Contact Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SOFTMARK

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CARDIOMEMS HF SYSTEM