BEUDAMED
    211 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

    Fluid, Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S)

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

    Computer-Assisted Personalized Sedation System

    FDA Pre-Market Approval
    FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Philips HeartStart FR3 Defibrillator

    Immunocytochemistry Assay, P16/Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·CINtec PLUS Cytology

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger

    Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

    FDA Pre-Market Approval
    FDA Class 3 ·LCS(R)TOTAL KNEE SYSTEM

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·KAMRA INLAY

    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS™) Liver

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Sientra Silicone Gel Breast Implants

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·KREMER LASER SYSTEM

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·OrganOx metra System