Lifetech Cardio Temporary Pacemaker

FDA 510(k)

FDA Class 2 ·Cardiovascular

Plastic LOR Syringe

FDA 510(k)

FDA Class 2 ·Anesthesiology

U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PlutoX Digital Intraoral X-Ray Imaging System

FDA 510(k)

FDA Class 2 ·Dental

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BraidE Embolization Assist Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAGNETOM SYMPHONY A TIM SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

TIDI BRAND STERILIZATION WRAP

FDA 510(k)

FDA Class 2 ·General Hospital

Safety Push Button Blood Collection Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HANAROSTENT Benefit Biliary (NNN)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Vented Vial Transfer Pin

FDA 510(k)

FDA Class 2 ·General Hospital

Portable X-ray System

FDA 510(k)

FDA Class 2 ·Dental

FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Pre-filled Syringe with Saline

FDA 510(k)

FDA Class 2 ·General Hospital

IPL Hair Removal, Model: OBT-02

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACQA

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETOM TRIO A TIM SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology