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

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTIEN Measurement System

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIVO

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Merge Hemo

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDIGUIDE TECHNOLOGY

FDA 510(k)

FDA Class 2 ·Cardiovascular

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Computer, Diagnostic, Programmable

FDA classification

FDA Class 2 ·Computer, Diagnostic, Programmable

Labware, Assisted Reproduction, Exempt

FDA classification

FDA Class 2 ·Labware, Assisted Reproduction, Exempt

Home Uterine Activity Monitor

FDA Pre-Market Approval

FDA Class 2 ·CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM

Home Uterine Activity Monitor

FDA Pre-Market Approval

FDA Class 2 ·SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM