BEUDAMED
    1,516 results · 29ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDX

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·KONTUR 55 EW

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VITALITY DS ICD SYSTEMS

    Implanted Fecal Incontinence Device

    FDA Pre-Market Approval
    FDA Class 3 ·AMS ACTICON NEOSPHINCTER

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4

    Valve, Pulmonary

    FDA Pre-Market Approval
    FDA Class 3 ·Pulmonx Zephyr Endobronchial Valve (EBV)

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·SEPRAFILM ADHESION BARRIER

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    FDA Pre-Market Approval
    FDA Class 3 ·CORMET HIP RESURFACING SYSTEM

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 630G Insulin Pump

    Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

    FDA Pre-Market Approval
    FDA Class 3 ·SLEEP SENTRY

    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·INFORM HER-2/NEU

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·REVO MRI IPG

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP Flex with SmartAssist

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·BIOTRONIK GEMNOS 04, 04A, AND TC 04

    Pulmonary Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent