BEUDAMED
    10,000 results · 42ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, and Compia MRI Quad

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·ZYPLAST COLLAGEN IMPLANT ZYDERM I AND II COLLAGEN IMPLANT

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Consulta CRT-P, Syncra CRT-P, and Viva CRT-P

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems

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

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE/IMMULITE 1000 Free PSA and IMMULITE 2000 Free PSA

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Envision Mammography Platform

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ADAPTA,VERSA,SENSIA,ADVISA DR,ADVISA DR MRI,ENPULSE E1,ENPULSE E2,ENRHYTHM,KAPPA D(KAPPA 700),KAPPA D (KAPPA 900) IPG, K

    System, Photopheresis, Extracorporeal

    FDA Pre-Market Approval
    FDA Class 3 ·THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS TORIC CALCULATOR

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·KAPPA & ENPULSE FAMILIES OF PACEMAKERS

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 2090 MEDTRONIC CARELINK PROGRAMMER

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT

    Automated Insulin Dosing , Threshold Suspend

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

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·SOFLENS

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·SUPARTZ FX

    Device, Removal, Pacemaker Electrode, Percutaneous

    FDA Pre-Market Approval
    FDA Class 3 ·CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROMUS PREMIER Everolimus-Eluting Platinum Chrominum Coronary Stent System