BEUDAMED
    10,000 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·MERLIN NET 6.1M

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Precision™, Precision Spectra™, Precision Novi™, Precision Montage™, Precision Montage™ MRI, Spectra WaveWriter, WaveWri

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROTHESIS

    Lithotripter, Shockwave (For Treating Gallbladder Stones)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Tendril SDX, Tendril ST, Tendril STS and Optisense leads

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvederm Voluma® XC and Juvederm Volbella® XC

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·PERMAFLEX NATURALS

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

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·SJM ACTIVE & PASSIVE LEADS

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MINIMED 530G SYSTEM

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

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

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EZ STEER

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCON G4 PLATINUM CGM

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM-ILIAC

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed Paradigm Real-Time Revel System

    Prostrate Cancer Genes Nucleic Acid Amplification Test System

    FDA Pre-Market Approval
    FDA Class 3 ·Progensa PCA3 Assay