BEUDAMED
    346 results · 33ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare HVAD System

    Ring, Endocapsular

    FDA Pre-Market Approval
    FDA Class 3 ·EYEJET INJECTOR

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx (F1CDx)

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·SVS APEX APEX EXIMER LASER WORKSTATION

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·FINELINE II STEROX & FINELINE II STEROX EZ, SUTURE SLEEVE ACCESSORY(FOR FINELINE II LEADS)

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·CyPass Micro-Stent

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

    FDA Pre-Market Approval
    FDA Class 3 ·CONTAK RENEWAL TR MODELS H120 AND H125

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

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

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·OPTUNE

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·EXTERNAL PULSE GENERATOR, 16 CHANNEL, EXTERNAL PULSE GENERATOR, 2 PORT HEADER

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·ENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER

    P2psa

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 035 DCB PTA Catheter Balloon

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

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

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HPV Assay

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Ranger Paclitaxel-Coated Balloon Catheter

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Ranger™ Paclitaxel-Coated Balloon Catheter

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY