PHARMASEAL CLEAR HUB SPINAL NEEDLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

ULTRA-COVER PU-TRANSDUCER COVER

FDA 510(k)

FDA Class 2 ·Radiology

HALO

FDA 510(k)

FDA Class 2 ·Radiology

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE

IMAGYS

FDA 510(k)

FDA Class 2 ·Radiology

SOFAMOR ORFIL SPINE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Caption Guidance

FDA 510(k)

FDA Class 2 ·Radiology

Caption Guidance

FDA 510(k)

FDA Class 2 ·Radiology

Caption Guidance

FDA 510(k)

FDA Class 2 ·Radiology

HeartFocus (V.1.1.1)

FDA 510(k)

FDA Class 2 ·Radiology

Cardiac Guidance

FDA 510(k)

FDA Class 2 ·Radiology

UltraSight AI Guidance

FDA 510(k)

FDA Class 2 ·Radiology

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