CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500

FDA 510(k)

FDA Class 2 ·Cardiovascular

STOCKERT SCP RHYTHM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Anivia SG1000 Pump Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-MEDICUS BIO CONSOLE MODELS 540 A B C

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLO TEM (FLUID WARNER)

FDA 510(k)

FDA Class 2 ·Hematology

CIRCULATING CYTO-THERMS

FDA 510(k)

FDA Class 2 ·Hematology

MODEL 114 TREONIC H150 HAEMOHEATER

FDA 510(k)

FDA Class 2 ·Hematology

ROCKING/CIRCULATING CYTO-THERM II 3570

FDA 510(k)

FDA Class 2 ·Hematology

VivoSight Dx Topical OCT System

FDA 510(k)

FDA Class 2 ·Radiology

OPTIS Metallic Stent Optimization E.4 SW

FDA 510(k)

FDA Class 2 ·Radiology

OPXION Optical Skin Viewer (OPXSV1-01F)

FDA 510(k)

FDA Class 2 ·Radiology

Ilumien Optis, Optis Integrated, Optis Mobile

FDA 510(k)

FDA Class 2 ·Radiology

Starlight Imaging Catheter

FDA 510(k)

FDA Class 2 ·Radiology

OTIS Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

FDA 510(k)

FDA Class 2 ·Radiology