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    Aelite Aesthetic Enamel

    FDA UDI
    BISCO INC.·00810111541534·Aelite Aesthetic Enamel Incisal Clear Syringe

    Joh. Th. Schulte b.v.

    Importer
    🇳🇱 Netherlands·1 Manufacturer

    KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-

    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)

    Stimulator, Neuromuscular, Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·Synergy Ablation System

    Implant, Anti-Gastroesophageal Reflux

    FDA Pre-Market Approval
    FDA Class 3 ·LINX Reflux Management System

    Implant, Anti-Gastroesophageal Reflux

    FDA Pre-Market Approval
    FDA Class 3 ·LINX REGLUX MANAGEMENT SYSTEM

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·Synergy Ablation System

    System, Nuclear Magnetic Resonance Imaging

    FDA Pre-Market Approval
    FDA Class 2 ·NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO

    System, Nuclear Magnetic Resonance Imaging

    FDA Pre-Market Approval
    FDA Class 2 ·TESLACON(TM) NMR IMAGING SYSTEM

    System, Nuclear Magnetic Resonance Imaging

    FDA Pre-Market Approval
    FDA Class 2 ·NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·MURINE CONTACT LENS CLEANER

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·EPi-Sense®, EPi-Sense ST™ Guided Coagulation System

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

    System, Nuclear Magnetic Resonance Imaging

    FDA Pre-Market Approval
    FDA Class 2 ·TESLACON(TM) NMR IMAGING 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)

    System, Nuclear Magnetic Resonance Imaging

    FDA Pre-Market Approval
    FDA Class 2 ·NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000