AFFINITY BLOOD PUMP SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS PORTABLE POWER MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

STOCKERT-SHILEY CAPS TIMER MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

GAMBRO PUMP CONSOLE CSL

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100

FDA 510(k)

FDA Class 2 ·Cardiovascular

Stockert S5 System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SORIN C5 SYSTEM MODEL 58-00-00

FDA 510(k)

FDA Class 2 ·Cardiovascular

STOCKERT COMPACT SYSTEM VERSION 2.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

Century Perfusion System

FDA 510(k)

FDA Class 2 ·Cardiovascular

STOCKERT CENTRIFUGAL PUMP CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Advanced Perfusion System 1

FDA 510(k)

FDA Class 2 ·Cardiovascular

Console, Heart-Lung Machine, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Console, Heart-Lung Machine, Cardiopulmonary Bypass

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·DTU-ONE ULTRASOUND SCANNER

A Breathing System (ABS)

FDA 510(k)

FDA Class 2 ·Neurology

ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT

FDA 510(k)

FDA Class 2 ·Hematology

CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY

FDA 510(k)

FDA Class 2 ·Radiology

CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0

FDA 510(k)

FDA Class 2 ·Radiology

Hintermann Series H2 Total Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

DTI-1 SLA IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental