HEMO-DIAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Capnograph and Oximeter

FDA 510(k)

FDA Class 2 ·Anesthesiology

CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mobility+ Enteral Feeding System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXLAB 3.6, ACCELERATOR A3600

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Mobility+ Enteral Feeding System OTC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

FDA 510(k)

FDA Class 2 ·Dental

Polibond

FDA 510(k)

FDA Class 2 ·Dental

ICE Ceramics, ICE Stains, Fresco

FDA 510(k)

FDA Class 2 ·Dental

Prettau, ICE, Z-White zirconia blanks

FDA 510(k)

FDA Class 2 ·Dental

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue

FDA 510(k)

FDA Class 2 ·Dental

Color Liquid, Vita Liquid

FDA 510(k)

FDA Class 2 ·Dental

ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

FDA 510(k)

FDA Class 2 ·Radiology

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA

FDA 510(k)

FDA Class 2 ·Dental

CMI MAGNETOCARDIOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol

DMi Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

LMNT O2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NexSite HD, Hemodialysis Step Tip Catheter (60cm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology