GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SCANLISA HUMAN CRP ELISA KIT

FDA 510(k)

FDA Class 2 ·Immunology

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Navistar EP, EZ Steer Nav Bi-Directional

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Navistar, Navistar RMT, EZ Steer Nav Bi-directional

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter

VersaPAP Positive Airway Pressure (PAP) Device

FDA 510(k)

FDA Class 2 ·Anesthesiology

RESPICONNECT ADAPTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Aerobika OPEP Devive with Manometer

FDA 510(k)

FDA Class 2 ·Anesthesiology

MC 300R* Nebulizer

FDA 510(k)

FDA Class 2 ·Anesthesiology

AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray

FDA 510(k)

FDA Class 2 ·Neurology

MONICA IF24

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Intellijoint HIP Generation 2B System

FDA 510(k)

FDA Class 2 ·Neurology

CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

AEROPEP

FDA 510(k)

FDA Class 2 ·Anesthesiology

AEROCHAMBER PLUS VALVED HOLDING CHAMBER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Combined Aerobika OPEP and VersaPAP device

FDA 510(k)

FDA Class 2 ·Anesthesiology

Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)

FDA 510(k)

FDA Class 2 ·Orthopedic