F&P Optiflow Flow Diverter

FDA 510(k)

FDA Class 2 ·Anesthesiology

VALVE, EXHALATION BE 115-4, 115-5

FDA 510(k)

FDA Class 2 ·Anesthesiology

EMS MOUTH TO MASK RESUSCITATORS

FDA 510(k)

FDA Class 2 ·Anesthesiology

PROTECTAIDE CPR PROTECTION PACK

FDA 510(k)

FDA Class 2 ·Anesthesiology

AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

RESCUE BREATHER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5

FDA 510(k)

FDA Class 2 ·Radiology

FIDIS CELIAC

FDA 510(k)

FDA Class 2 ·Immunology

Dyna-Vision Telemonitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAGLIFE C/MAGLIFE C PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables

FDA 510(k)

FDA Class 2 ·Cardiovascular

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0

ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

FDA 510(k)

FDA Class 2 ·Hematology

ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROS 60

FDA 510(k)

FDA Class 2 ·Hematology

PENTRA XLR

FDA 510(k)

FDA Class 2 ·Hematology