BEUDAMED
    82 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA Pre-Market Approval
    FDA Class 3 ·STAR PSI System

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT/ANTI-HBS CALIBRATORS

    Temporary Non-Roller Type Left Heart Support Blood Pump

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

    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

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA Implant System

    Hepatitis Delta Serological Reagents

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)

    Hepatitis Delta Serological Reagents

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ANTI-DELTA EIA

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA Implant System

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA™ Implant System

    Hepatitis Delta Serological Reagents

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA Implant System

    Implant, Dermal, For Aesthetic Use In The Hands

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane Lyft with Lidocaine

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA System

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

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

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA Implant System

    Hepatitis Delta Serological Reagents

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ANTI-DELTA (EIA) ASSAY

    Implant, Dermal, For Aesthetic Use In The Hands

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA 2.5 System

    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

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

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·BETA-CATH (TM) SYSTEM