MODEL 1812 CONTROL CONSOLE, ACCESSORIEX

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-CONSOLE, MODEL 560

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150

FDA 510(k)

FDA Class 2 ·Cardiovascular

LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E

FDA 510(k)

FDA Class 2 ·Cardiovascular

Anivia SG1000 Pump Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

One Step Amphetamine (AMP) Test Kit (Urine) (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device

One Step Amphetamine (AMP) Test Kit(Hair) (Colloidal Gold )

Basic UDI-DI

EU IVDD · Eu Ivd General ·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device

Pump, Drug Administration, Closed Loop

FDA Pre-Market Approval

FDA Class 3 ·GENESA(R) SYSTEM