MICROCAPILLARY INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST

FDA 510(k)

FDA Class 2 ·Immunology

EYE SPOT IM TEST

FDA 510(k)

FDA Class 2 ·Immunology

DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID

FDA 510(k)

FDA Class 2 ·Hematology

J&S HDL CHOLESTEROL PRECIPITATING REAGENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AST (SGOT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TUBING PACK, EXTRACORPOREAL, H-3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nautilus VF ECMO Oxygenator

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nautilus Smart ECMO Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO

FDA 510(k)

FDA Class 2 ·Orthopedic

SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·POTASSIUM PENICILLIN G DIAG SYS POWDER

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS

CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L

FDA 510(k)

FDA Class 2 ·Anesthesiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS