MODIFIED GAS-STAT(TM) MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CDI (TM) SYSTEM 100 MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DUROMEDICS CARDIAC VALVE SIZER SET

FDA 510(k)

FDA Class 1 ·Cardiovascular

METRONIC MODEL F7700 HEART VALVE SIZERS

FDA 510(k)

FDA Class 1 ·Cardiovascular

MAQUET HL-20 System

FDA UDI

Maquet Cardiopulmonary AG·04037691786544·The DTI 1/4"x1/16" (2 pcs) is a Double Tube In...

MAQUET HL-20 System

FDA UDI

Maquet Cardiopulmonary AG·04037691211190·The DTI 1/4"x1/16" (2 pcs) is a Double Tube In...

Prism Process

FDA UDI

PRISM CLINICAL IMAGING, INC.·B358PCI01PP0·Prism Process® software is used in conjunction ...

BioK TE

FDA registration

BIOLENS LAB·1 product·🇲🇦 Morocco

Tyber Medical

FDA UDI

Tyber Medical LLC·M695401204291·

Assay, Oral Direct Thrombin Inhibitor

FDA classification

FDA Not Classified ·Assay, Oral Direct Thrombin Inhibitor

Prism View

FDA UDI

PRISM CLINICAL IMAGING, INC.·B358PCI01PV0·Prism View provides both analysis and viewing c...

Prism View

FDA UDI

PRISM CLINICAL IMAGING, INC.·B358PCI01PV410·Prism View provides both analysis and viewing c...

Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

Sizer, Heart-Valve, Prosthesis

FDA classification

FDA Class 1 ·Sizer, Heart-Valve, Prosthesis

FUNCTIONAL MR

FDA UDI

Olea Medical USA·EOLEFMRIV1P00·Functional MR V1.0 is an optional image process...

nordicBrainEx

FDA UDI

Nordicneurolab AS·07090042059015·The nordicBrainEx Software is a post-processing...

ATYS MEDICAL SAS

Manufacturer

🇫🇷 France

Idys ALIF 3DTi

FDA registration

CEFIMECA·1 product·🇫🇷 France

AccuPlan System 3DTi

FDA registration

MedCAD·2 products·🇺🇸 United States

Idys™ TLIF 3DTi

FDA registration

CLARIANCE-SAS·1 product·🇫🇷 France