PITANGA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)

FDA 510(k)

FDA Class 2 ·General Hospital

SENSILIGHT MINI

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GLIDE DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Mazor X

FDA 510(k)

FDA Class 2 ·Neurology

Brainsway Deep TMS System

FDA 510(k)

FDA Class 2 ·Neurology

Inessa System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Vented Vial Adapter Transfer Device - 13mm

FDA 510(k)

FDA Class 2 ·General Hospital

Trans-anal Introducer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

C-INSIGHT

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO ENVOY PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

LYMPHA PRESS OPTIMAL, MODEL# 1201AP

FDA 510(k)

FDA Class 2 ·Cardiovascular

NAVIAID(TM) BGC DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDITECH MODEL ABPM-04

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIXION HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SMARTFLOW, MODEL SFIP 2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777

FDA 510(k)

FDA Class 2 ·Physical Medicine

X-Suit NIR Biliary Metallic Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

iTero Lumina™ Pro

FDA 510(k)

FDA Class 2 ·Dental

DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology