IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

FDA 510(k)

FDA Class 2 ·Neurology

IMRIS ONCOLOGY PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

CORTEX DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CHEETAH RELIANT, CHEETAH ACTIVE

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

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

SURPASSON P5 NEWTRON

FDA 510(k)

FDA Class 2 ·Dental

ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA TPU CAL, MODEL A11A01898

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA URINE CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

ELCAM STOPCOCKS AND MANIFOLDS

FDA 510(k)

FDA Class 2 ·General Hospital