THE REMOTE

FDA 510(k)

FDA Class 2 ·Radiology

WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PYRAMIDION Dental Implants and Prostheses

FDA 510(k)

FDA Class 2 ·Dental

SILK'N

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLASH N' GO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SILK'N FLASH N GO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FEP RINGED GORE-TEX VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX

FDA 510(k)

FDA Class 2 ·Cardiovascular

Comaneci, Comaneci Petit, Comaneci 17

FDA 510(k)

FDA Class 2 ·Neurology

FRACTORA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RAPID Web

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Geneo X Elite

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

DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ReDs Wearable System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PEERSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PillCam Patency System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOXOM IRRIGATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OGmend Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic