BEUDAMED
    150 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 2 ×

    Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Access PCT, Access PCT Calibrators

    FDA 510(k)
    FDA Class 2 ·Microbiology

    System, Imaging, Optical Coherence Tomography (Oct)

    FDA classification
    FDA Class 2 ·System, Imaging, Optical Coherence Tomography (Oct)

    Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

    FDA classification
    FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

    Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

    FDA classification
    FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

    Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

    FDA classification
    FDA Class 2 ·Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

    Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

    FDA classification
    FDA Class 2 ·Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

    FDA classification
    FDA Class 2 ·Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

    HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head

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