ICX-Implant System

FDA 510(k)

FDA Class 2 ·Dental

COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

GRAFTCAGE ACX

FDA 510(k)

FDA Class 2 ·Orthopedic

ICAN GT DRAINAGE BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ICAN NEEDLE COUNTERS

FDA 510(k)

FDA Class 2 ·General Hospital

(SPAG) MODEL SPAG-2 6000 SERIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

WATER COLUMN RELIEF VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Neuronaute Plus

FDA 510(k)

FDA Class 2 ·Neurology

iCE-SG Subcutaneous Electrode Arrays

FDA 510(k)

FDA Class 2 ·Neurology

iCEWav Neuromonitoring Platform

FDA 510(k)

FDA Class 2 ·Neurology

iCE-SG2 Subcutaneous Electrode Kit

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACX RX COMET VP CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·HARTZLER ACX II(R) CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS HARTZLER ACX II CORONARY DILATATION BALLOON CA

Neuronaute

FDA 510(k)

FDA Class 2 ·Neurology

Neuronaute with IceCap 2 & IceCap 2 Small

FDA 510(k)

FDA Class 2 ·Neurology

Nutricare Clear-ISOSAF Nasogastric Feeding Tube

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry