BEUDAMED
    540 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·RX ACCULINK CAROTID STENT SYSTEM

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER Duct Occluder II

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Azure and Astra MRI SureScan IPG and Pacing System

    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS®) Liver™

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

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Oncomine Dx Target Test

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Attain Ability Straight Left Ventricular Lead

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline Flex Embolization Device

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Radiesse Injectable Implant

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·Minerva Endometrial Ablation System

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MedEl EAS System

    Aspiration Therapy System

    FDA Pre-Market Approval
    FDA Class 3 ·Pathway Clinical Trial Cohort

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC DEEP BRAIN STIMULATION (DBS) THERAPY

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”)