ADR-2000 AMBULATORY DATA RECORDING SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

VIA-GUARD

FDA 510(k)

FDA Class 2 ·General Hospital

Surgeon Controlled Arm

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BrachyGel Vaginal Hydrogel Packing System

FDA 510(k)

FDA Class 2 ·Radiology

STABILIZ FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NANOSS BONE VOID FILLER

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE

FDA 510(k)

FDA Class 2 ·Cardiovascular

STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

TRUFREEZE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Burn Resuscitation Decision Support System - Clinical (BRDSS-C)

FDA 510(k)

FDA Class 2 ·Anesthesiology

RADIANCE 330 PROTON THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ONCO TRAC MODEL 1, 2, 4

FDA 510(k)

FDA Class 2 ·Radiology

SIM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MR EXTENSION SET (001)

FDA 510(k)

FDA Class 2 ·General Hospital

VIPOR UNIT

FDA 510(k)

FDA Class 2 ·Radiology

Albumin, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Albumin, Fitc, Antigen, Antiserum, Control

Flow Cytometric Test System For Hematopoietic Neoplasms

FDA classification

FDA Class 2 ·Flow Cytometric Test System For Hematopoietic Neoplasms

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH LITHOTRIPTER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ADAPPTE ARTIFICIAL TEAR

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MIC TEST PANELS