electrocardiograph: SE-1202

FDA 510(k)

FDA Class 2 ·Cardiovascular

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FLEXIBLE INTRACARDIAC SUCTION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

FDA 510(k)

FDA Class 2 ·Immunology

Disposable Laryngeal Electrodes

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

CATHCAP, CAT. NO. CC100 SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

Repagyn vaginal suppositories

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SIRIO H3

FDA 510(k)

FDA Class 2 ·Radiology

Streamline MIS Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUROLINK IP MODEL: PK1117

FDA 510(k)

FDA Class 2 ·Neurology