BEUDAMED
    3,114 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre 14 day Flash Glucose Monitoring System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ADAPTA/VERSA/SENSIA IPG

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·SJM ICDS

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000, 7000TFX

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·VOYAGER NC CORONARY DILATATION CATHETER

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL BALLOON CATHETER

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

    FDA Pre-Market Approval
    FDA Class 3 ·RF Filter Module

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY™ XD Everolimus-Eluting Platinum Chromium Co

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra TPS

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP

    Transcervical Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·Essure System for Permanent Birth Control (Model ESS305)

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM (SUPERB)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR XP PSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)

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

    FDA Pre-Market Approval
    FDA Class 3 ·PARADYM VR 8250, PARADYM DR 8550, PARADYM CRT-D 8750, PARADYM RF VR 9250, PARADYM RF DR 9550, PARADYM M RF CRT-D 9750

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATIONS SOFTWARE

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·COFLEX® INTERLAMINAR TECHNOLOGY

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System