BELTER BLOOD PRESSURE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUNRAY FETAL MONITOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Jmoon Conductive Gel

FDA 510(k)

FDA Class 2 ·Neurology

Dental Lithium Disilicate Glass-Ceramic

FDA 510(k)

FDA Class 2 ·Dental

BELTER INFRA-RED EAR THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Uterine Manipulator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Myflon Surgical Mask Level 3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dental Glass Ceramics Blocks (HT, LT, MT)

FDA 510(k)

FDA Class 2 ·Dental

Altera Filter and HME/Filter

FDA 510(k)

FDA Class 2 ·Anesthesiology

Smart Peak Flow Meter

FDA 510(k)

FDA Class 2 ·Anesthesiology

InferRead CT Stroke.AI

FDA 510(k)

FDA Class 2 ·Radiology

M. DIOR BRAND

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

iBSM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hipro Glycosylated Hemoglobin (HbA1c) Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Intravascular Administration Set, Automated Air Removal System

FDA classification

FDA Class 2 ·Intravascular Administration Set, Automated Air Removal System

Lifetech Cardio Temporary Pacemaker

FDA 510(k)

FDA Class 2 ·Cardiovascular

Dental Barrier and Sleeves

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ameda GLO Wearable Breast Pump (Model W8S)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Fractional CO2 Laser Therapy System (EXFU CO2)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery