BEUDAMED
    3,822 results · 60ms · Sources: EU EUDAMED, US FDA

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·Dimension TPSA Flex reagent cartridge

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·Dimension TPSA Flex reagent cartridge

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

    AFC Support Stand

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·The Magstim Company Limited·3 devices

    Flexi-Seal PROTECT Fecal Management System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIMENSION EXL WITH LM SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GentleCath Glide Intermittent Urinary Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology