AURORA DS, DS APPLICATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pure-Vu EVS System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

P-ART, MODEL 001

FDA 510(k)

FDA Class 2 ·Radiology

COLONOSIGHT MODEL 510B

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO: HORIZON 9000WS

FDA 510(k)

FDA Class 2 ·Cardiovascular

PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Piccolo Composite® Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

neoLaser Laser Surgery Fibers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

SlimShape System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BINGO PRO

FDA 510(k)

FDA Unclassified ·Unknown

V10 system

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pristine Hemodialysis Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SilverStream Gel

FDA 510(k)

FDA Unclassified ·Unknown

ScleroSafe™ 150 mm, ScleroSafe™ 350 mm

FDA 510(k)

FDA Class 2 ·Cardiovascular

GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pulsehaler

FDA 510(k)

FDA Class 2 ·Anesthesiology

THROAT-A-SCOPE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

MICROSTREAM EXTERNAL BATTERY CHARGER

FDA 510(k)

FDA Class 2 ·Anesthesiology