BEUDAMED
    10,000 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·G4 PLATINUM Continuous Glucose Monitoring System and G5 Mobile Continuous Glucose Monitoring System

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·Diamondback 360 Orbital Atherectomy and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS)

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·EON NEUROSTIMULATION (IPG), ANS EON C NEUROSTIMULATION (IPG), AND EON MINI NEUROSTIMULATION(IPG)

    Ventricular (Assist) Bypass

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

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·SYNERGY EVEROLIMUS ELUTING PLATINUM CHROMIUN CORONARY STENT SYSTEM MONORAIL & OVER THE WIRE.

    Agent, Absorbable Hemostatic, Collagen Based

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CONTAK CD, EASYTRAK, LIVIAN, COGNIS, ACUITY SPIRAL, ENERGEN, PUNCTUA, & INCEPTA CRT-D'S

    Intraocular Lens

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

    Kit, Dna Detection, Human Papillomavirus

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

    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

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.0/LD Systems

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

    FDA Pre-Market Approval
    FDA Class 3 ·CURRENT/PROMOTE, CURRENT ACCEL/PROMOTE ACCELL & CURRENT+/PROMOTE+FAMILIES ICDS/CRT-DS

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIMUM CORONARY STENT SYSTEM MONORAIL & OVER-THE-WIRE.

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 0063

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·VISCOAT & PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (LATEX-FREE PACKAGING CONFIGURATION ONLY FOR PROVISC)

    Material, Dressing, Surgical, Polylactic Acid

    FDA Pre-Market Approval
    FDA Class 3 ·CollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·MCGHAN RTV SALINE-FILLED BREAST IMPLANTS - STYLES 68, 163, 168, 363 AND 468