BEUDAMED
    1,104 results · 36ms · Sources: EU EUDAMED, US FDA
    Filters FDA Pre Market Approval ×

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He

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

    FDA Pre-Market Approval
    FDA Class 3 ·MEMORYSHAPE BREAST IMPLANTS, CONTOUR PROFILE GEL IMPLANTS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Multifocal Toric II Intraocular Lenses

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·COMPLETE BRAND LUBRICATING AND REWETTING DROPS

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·INTERCEED ABSORBABLE ADHESION BARRIER

    FDA Pre-Market Approval
    MODEL 7271 ICD

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·Arctic Front Advance Cardiac Cryoablation Catheters

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC MODEL 7219B, 7219E, AND 7202E ARRYTHMIA MANAGEMENT DEVICES.

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM

    Pulmonary Valve Prosthesis Percutaneously Delivered

    FDA Pre-Market Approval
    9600CR Crimper

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·9600CR Crimper

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Optune System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F