BEUDAMED
    10,000 results · 45ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent - Microfibrillar Fo

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane, Perlane, Restylane-L, Restylane Lyft with Lidocane and Restylane Silk Injectable Gels

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Valve, and Edwards Pericardial Mitral Bioprosthesis

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular Lenses

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELS

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Helistat Absorable Collagen Hemostatic Agent and Helitene Absorable Collagen Hemostatic Agent Fibrillar Form

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TORIC LENS BENCH WITH RENISHAW GAUGE ACRYSOF TORIC & ACRYSOF IQ INTRAOCULAR LENSES

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo

    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

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Form

    Catheter, Percutaneous, Long Term, Intraspinal

    FDA Pre-Market Approval
    FDA Class 3 ·PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Series Product Line / Implantable Penile Prosthesis with and without InhibiZone Treatment

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Clinician Programmer Application Version 2.0.2, and Liberta RC DBS IPG Firmware Version 1.1.1

    Coronary Drug-Eluting Stent

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

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Enhancements to Software Model 9986 version 2.11.1 and Model SW028 to version 8.2.1

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Valitude, Valitude X4, Visionist, and Visionist X4 Cardiac Resynchronization Therapy - Pacemaker (CRT-P)

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone, AMS Ambicor IPP