BEUDAMED
    4,523 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer

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

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur Anti-HBe2 (aHBe2) assay

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER

    Immunohistochemistry Assay, Antibody, Folr1

    FDA classification
    FDA Class 3 ·Immunohistochemistry Assay, Antibody, Folr1

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

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANT

    DJP UNIPOLAR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    EKG TRANSMITTER MODEL 5134

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    HEARTSTART 1000S

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    EDP-20 PACEMAKER

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DJ UNIPOLAR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CODEMASTER XL + XL W/SHOCK ADVISORY OPTION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BIOTRONIK PERMANENT PACEMAKER ELECTRODE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PIKOS 01 & PIKOS E 01

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular