TVC Imaging System, TVC Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5

FDA 510(k)

FDA Class 2 ·Cardiovascular

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Starlight Imaging Catheter

FDA registration

SPECTRAWAVE, INC.·4 products·🇺🇸 United States

ISOMEDIX OPERATIONS INC.

FDA registration

ISOMEDIX OPERATIONS INC.·4 products·🇺🇸 United States

ISOMEDIX OPERATIONS INC.

FDA registration

ISOMEDIX OPERATIONS INC.·4 products·🇺🇸 United States

TVC Insight™

FDA UDI

INFRAREDX, INC.·00857595006203·Insight Catheter™ Kit The TVC Insight Catheter...

Catheter, Intravascular, Plaque Morphology Evaluation

FDA classification

FDA Class 2 ·Catheter, Intravascular, Plaque Morphology Evaluation

EGZ / Holder, film, x-ray

FDA registration

SURGICRAFTS·1 product·🇵🇰 Pakistan

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·OG(R) CARDIAC PACING SYSTEM

OG-6

FDA registration

SLMP LLC d.b.a. StatLab Medical Products·1 product·🇺🇸 United States

OG-6

FDA registration

SSN SOLUTIONS·1 product·🇺🇸 United States

JGS - ELECTRODE, ION SPECIFIC, SODIUM JFP - ELECTRODE, ION SPECIFIC, CALCIUM CGZ - ELECTRODE, ION-SPECIFIC, CHLORIDE

FDA registration

Siemens Healthcare Diagnostics Inc.·6 products·🇺🇸 United States

OGI

FDA registration

OGI, LLC·1 product·🇺🇸 United States

SCOJO

FDA registration

OGI, LLC·1 product·🇺🇸 United States

Red Rose

FDA registration

OGI, LLC·1 product·🇺🇸 United States

ANSEN CORPORATION

FDA registration

ANSEN CORPORATION·1 product·🇺🇸 United States

ANSEN CORPORATION

FDA registration

ANSEN CORPORATION·1 product·🇺🇸 United States

LITM INC.

FDA registration

LITM INC.·1 product·🇯🇵 Japan