IQM Integral Quality Monitor (also IQM)

FDA 510(k)

FDA Class 2 ·Radiology

GAMBRO DQM 200

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MAM COOLER

FDA 510(k)

FDA Class 2 ·Dental

MAM TWISTER

FDA 510(k)

FDA Class 2 ·Dental

UNIVERSAL STAND FOR FILM CHANGER

FDA 510(k)

FDA Class 2 ·Radiology

IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PHYCON ALL SILICONE BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

B-CAD SYSTEM, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM

FDA 510(k)

FDA Class 2 ·Anesthesiology

LASER SHIELDING TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV

FDA 510(k)

FDA Class 2 ·Microbiology

GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I

FDA 510(k)

FDA Class 2 ·Microbiology

HERPES EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·THOR PTCA DILATATION CATHETERS WITH 10 MM AND 40 MM LONG BALLOONS

GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETER WITH 3.5 MM BALLOON

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SLIDER(TM)/2.0 MM BALLOON DILATION CATHETER