DISINFECTION WITH THE COX DRY HEAT STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4

FDA 510(k)

FDA Class 2 ·Orthopedic

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5

FDA 510(k)

FDA Class 2 ·Orthopedic

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k)

FDA Class 2 ·Immunology

AXIS 5.5 Lumbar Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Axis Chena Cervical PEEK Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

Axis Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

ELECTRONIC CELL ENERGIZER

FDA 510(k)

FDA Class 2 ·Physical Medicine

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

TENSMED II

FDA 510(k)

FDA Class 2 ·Neurology

INTERCEPTOR, 662-01

FDA 510(k)

FDA Class 2 ·Neurology

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