NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LINE CO2 NASAL CANNULA SAMPLE LINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

OPTION 301 PACEMAKER EVAL. MODULE MAC-1

FDA 510(k)

FDA Class 2 ·Cardiovascular

Movement and Compressions System (the MAC System)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intraosseous Cannula System Bio-MAC¿ and Bio-CORE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS

FDA 510(k)

FDA Class 2 ·Cardiovascular