Optilite IgM CSF Kit

FDA 510(k)

FDA Class 2 ·Immunology

Optilite IgM Kit

FDA 510(k)

FDA Class 2 ·Immunology

Human IgM Kit for use on SPAPlus

FDA 510(k)

FDA Class 2 ·Immunology

External Counterpulsation System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)

FDA 510(k)

FDA Class 2 ·Cardiovascular

WavelinQ 4F EndoAVF System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ellipsys Vascular Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

WavelinQ Plus EndoAVF System

FDA 510(k)

FDA Class 2 ·Cardiovascular

everlinQ endoAVF System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDRAD SPECTRIS MR INJECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDRAD QWIK-FIX MRI DISPOSABLE KIT

FDA 510(k)

FDA Class 2 ·Radiology

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

TELEVISIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

B-CAD SYSTEM, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology