AngioCloud Service

FDA 510(k)

FDA Class 2 ·Radiology

ExoToe Staple

FDA 510(k)

FDA Class 2 ·Orthopedic

OMNYX IDP FOR HER2 MANUAL APPLICATION

FDA 510(k)

FDA Class 2 ·Hematology

3.0T METAFLEXCOIL

FDA 510(k)

FDA Class 2 ·Radiology

TITANEX Screw Systems

FDA 510(k)

FDA Class 2 ·Orthopedic

Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

METAL HEMI IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F

FDA 510(k)

FDA Class 2 ·Radiology

Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC

FDA 510(k)

FDA Class 2 ·Cardiovascular

LITECURE THERAPY COMPACT

FDA 510(k)

FDA Class 2 ·Physical Medicine

Natureplex Warm Touch Warming Jelly

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

APRO 55 Catheter and Alembic Aspiration Tubing

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTOSNARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EUROPA™ Posterior Cervical Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

TABLET COMMANDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OSSEOFLEX SB

FDA 510(k)

FDA Class 2 ·Orthopedic

Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley

FDA 510(k)

FDA Class 2 ·Radiology

LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery