BEUDAMED
    599 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL M SERIES 12SL ANALYSIS OPTION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OPUS S MODEL 4121 AND 4124 PACEMAKERS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DF-1 TERMINAL CAP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    JUMP START, MODEL 970300

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    FIRSTSAVE BIPHASIC MODELS 9200 AND 9210

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G4® PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·METHAFILCON A

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BAUSCH & LOMB PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS FREE PSA

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

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·Dimension Vista FPSA Flex reagent cartridge (K6452)