BEUDAMED
    474 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT TOTAL PSA

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Progel Pleural Air Leak Sealant (Progel™ PALS)

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Etrinsa 8 HF-T, Epyra 8 HF-T, and Eluna 8 HF-T

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT FREE PSA

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Dromos DR/SR Rate Adaptive Pacing Systems

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBSAG QUAL/CONF

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·RENEWAL TR FAMILY

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Tridyne Vascular Sealant (Tridyne™ VS)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F)

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT Total PSA Reagent/Calibrator/Control Kit

    Ablation Catheter, Renal Denervation

    FDA Pre-Market Approval
    FDA Class 3 ·Paradise Ultrasound Renal Denervation System, Paradise Generator

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY SYSTEM (RX AND OTW)

    System, Oxygen, Aqueous

    FDA Pre-Market Approval
    FDA Class 3 ·TherOx DownStream System

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Precision7 ™, Precision7 ™ for Astigmatism, Precision7 ™ Multifocal, Precision7 ™ Multifocal Toric

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·OXYCELL

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LUTONIX DRUG COATED BALLOON

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra Transcatheter Pacing System