BEUDAMED
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    Nexcomp

    FDA 510(k)
    FDA Class 2 ·Dental

    CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VONFLEX HEAVY, VINFLEX LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CeraSeal

    FDA 510(k)
    FDA Class 2 ·Dental

    HABIB VESEAL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HABIB HEXABLATE 10

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Alleye

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    HABIB HEXABLATE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HABIB ENDOBLATE

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

    HABIB ENDOHPB

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

    Test, Urea Adult And Pediatric (Breath),

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

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, CP, and CP with SmartAssist

    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, Impella 5.0, and Impella LD Systems

    Temporary Non-Roller Type Left Heart Support Blood Pump

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

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·PyloPlus® UBT System

    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

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella CP Ventricular Support System

    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)

    Test, Urea Adult And Pediatric (Breath),

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