15 results · 7ms · Sources: EU EUDAMED, US FDA

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Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS

FDA 510(k)
FDA Class 2 ·Radiology

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ExSpiron 1Xi

FDA 510(k)
FDA Class 2 ·Anesthesiology

ExSpiron 1Xi

FDA 510(k)
FDA Class 2 ·Anesthesiology

ExSpiron 2Xi

FDA 510(k)
FDA Class 2 ·Anesthesiology

EXSPIRON 1XI

FDA 510(k)
FDA Class 2 ·Anesthesiology

Sterilizer, Dry Heat

FDA classification
FDA Class 2 ·Sterilizer, Dry Heat

Complement C1r, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Complement C1r, Antigen, Antiserum, Control

Device, Fluidized Therapy, Dry Heat

FDA classification
FDA Class 2 ·Device, Fluidized Therapy, Dry Heat

Intranasal Electrostimulation Device For Dry Eye Symptoms

FDA classification
FDA Class 2 ·Intranasal Electrostimulation Device For Dry Eye Symptoms

Intense Pulsed Light Device For Managing Dry Eye

FDA classification
FDA Class 2 ·Intense Pulsed Light Device For Managing Dry Eye

Light Based Device For Dry Age-Related Macular Degeneration

FDA classification
FDA Class 2 ·Light Based Device For Dry Age-Related Macular Degeneration

Di (O-Hydroxyphenylimine) Ethane, Calcium

FDA classification
FDA Class 2 ·Di (O-Hydroxyphenylimine) Ethane, Calcium