GlucoSure Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

FDA 510(k)

FDA Class 2 ·Cardiovascular

UPJ Occlusion Balloon Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Electric Breast Pump (F5055)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADVIA CHEMISTRY ENZYMATIC CREATININE_2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS

FDA 510(k)

FDA Class 2 ·Hematology

DENTLIGHT ORAL EXAM LIGHT KIT

FDA 510(k)

FDA Class 2 ·Dental

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sterile Hypodermic Syringe for Single Use

FDA 510(k)

FDA Class 2 ·General Hospital

Bashan TDP Heat Lamp

FDA 510(k)

FDA Class 2 ·Physical Medicine

aprevo® anterior lumbar interbody fusion device with interfixation

FDA 510(k)

FDA Class 2 ·Orthopedic

Diode Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Electric Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Dermatological Diode Laser Systems

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Portable ECG Monitor (ECG3)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Peel-Away Introducer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTERMITTENT PNEUMATIC COMPRESSION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular