BEUDAMED
    10,000 results · 61ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·HiResolution Bionic Ear System

    Sealant, Polymerizing

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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Saluda Medical Evoke SCS System

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Catheter, Percutaneous, Long Term, Intraspinal

    FDA Pre-Market Approval
    FDA Class 3 ·PORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·APLIGRAF (GRAFTSKIN)

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·HBV ASSAY

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA VENTRICULAR SUPPORT SYSTEMS

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·TRANSCYTE (DERMAGRAFT-TC)

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MICRO-DRIVER OVER-THE-WIRE CORONARY STENT SYSTEM AND MICRO-DRIVER MX2 CORONARY STENT SYSTEM

    Inhibitor, Peridural Fibrosis (Adhesion Barrier)

    FDA Pre-Market Approval
    FDA Class 3 ·ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL

    Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

    FDA Pre-Market Approval
    FDA Class 3 ·NeuRX Diaphragm Pacing System (DPS)

    Sensor, Glucose, Invasive

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

    Automated Breast Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·Invenia ABUS Premium, Invenia ABUS Prime

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·S670 OVER-THE-WIRE CORONARY STENT SYSTEM

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS)