KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

FDA 510(k)

FDA Class 2 ·Immunology

Cloud Smart Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28

FDA 510(k)

FDA Class 2 ·Radiology

Medical Disposable Sterile Needle Electrode

FDA 510(k)

FDA Class 2 ·Neurology

BV Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit

FDA 510(k)

FDA Class 2 ·Immunology

Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electrocardiograph

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500

FDA 510(k)

FDA Class 2 ·Immunology

IMX HOMOCYSTEINE

FDA 510(k)

FDA Class 2 ·Immunology

ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFICATION TO IMX HOMOCYSTEINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR

FDA 510(k)

FDA Class 2 ·General Hospital

AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

airVata™

FDA 510(k)

FDA Class 2 ·Dental

GENTLE COLON (REVISION 2.0)

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO CONTOUR SE MICROSPHERES

FDA 510(k)

FDA Class 2 ·Neurology

TrueTear Intranasal Tear Neurostimulator

FDA 510(k)

FDA Class 2 ·Ophthalmic

TrueTear Intranasal Tear Neurostimulator

FDA 510(k)

FDA Class 2 ·Ophthalmic

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors

FDA 510(k)

FDA Class 2 ·Anesthesiology