SUMO ACCESS AND TISSUE RESECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANNE Chest

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANNE Limb

FDA 510(k)

FDA Class 2 ·Cardiovascular

MSA100BT Peak Flow Meter

FDA 510(k)

FDA Class 2 ·Anesthesiology

ANNE View, Central Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

FDA 510(k)

FDA Class 2 ·Neurology

Self-adhesive Electrode

FDA 510(k)

FDA Class 2 ·Neurology

Orthopedic Fixation Pin

FDA 510(k)

FDA Class 2 ·Orthopedic

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OVA1 Next Generation

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LED Curing Light

FDA 510(k)

FDA Class 2 ·Dental

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medical Protective Masks

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Acessa ProVu System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sureclear aligners

FDA 510(k)

FDA Class 2 ·Dental

Medical Protective Masks

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

FDA 510(k)

FDA Class 2 ·Neurology

Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)

FDA 510(k)

FDA Class 2 ·Dental

Color Doppler Ultrasound System; Model: mEye1 and mEye2

FDA 510(k)

FDA Class 2 ·Radiology