IceSense 3, ProSense, MultiSense

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TOUAREG CloseFit™ UNP 2.75mmD

FDA 510(k)

FDA Class 2 ·Dental

Drakon and Sequre Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

CO2RE System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OSSIX PLUS

FDA 510(k)

FDA Class 2 ·Dental

P-ARTIS

FDA 510(k)

FDA Class 2 ·Radiology

I.V. FILTER SET

FDA 510(k)

FDA Class 2 ·General Hospital

DUET SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

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