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

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·ZYDERM COLLAGEN IMPLANT (ZYDERM CI)

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS

    Bronchial Thermoplasty System

    FDA Pre-Market Approval
    FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

    Drug-Eluting Sinus Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROPEL MINI SINUS IMPLANT

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·HYDROVIEW IOLS

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous-Transluminal Angioplasty Balloon Catheter

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Durata and Optisure Leads (HV Active and Passive)

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    Permanent Pacemaker Electrode

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

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·DEFLUX INJECTABLE GEL

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EZ STEER NAV ELECTROPHYSIOLOGY CATHETER

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

    FDA Pre-Market Approval
    FDA Class 3 ·FAMILY OF CRT-DS

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 630G System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Durata, Optisure

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·Simplera™ System

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·CELSIUS THERMOCOOL, THERMOCOOL SF, THERMOCOOL SMARTTOUCH SF, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, and THERMOCOOL SM