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

MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

ELECTRONIC PULSE STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

Massage Compression Boots

FDA 510(k)

FDA Class 2 ·Physical Medicine

BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Patient Monitoring Cables

FDA 510(k)

FDA Class 2 ·Cardiovascular

JKH Stimulator Plus

FDA 510(k)

FDA Class 2 ·Neurology

INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET

FDA 510(k)

FDA Class 2 ·Cardiovascular