COSMED K5 Wearable Metabolic Technology

FDA 510(k)

FDA Class 2 ·Anesthesiology

ELECTRONIC PULSE STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

Wearable Breast Pump (Model S10)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

FDA 510(k)

FDA Class 2 ·Immunology

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

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

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

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST VERSION 2.0