BEUDAMED
    382 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT REALTIME HVB ASSAY

    System, Hemodynamic, Implantable

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

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·MynxGrip, Mynx Ace, and Mynx Control Vascular Closure Device (VCD)

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·digene HC2 High-Risk HPB DNA Test and digene HC2 HPV DNA Test

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·Apollo Onyx Delivery Micro Catheter, 1.5cm, Straight/Apollo Onyx Delivery Micro Catheter, 3.0cm, Straight

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Certitude Introducer Sheath Set

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·SOF-SENSOR GLUCOSE SENSOR

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·Express LD Iliac Premounted Stent System

    Iliac Covered Stent, Arterial

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bulkamid Urethral Bulking System

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheters

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·Watchman Left Atrial Appendage Closure Technology

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LUTONIX® 035 Drug Coated Balloon PTA Catheter

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvéderm Voluma XC

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Sapien 3 Ultra Delivery System and Edwards Commander Delivery System

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·DEFLUX INJECTABLE GEL

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon System

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon Kit