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FORE-SIGHT ELITE Absolute Tissue Oximeter

FDA 510(k)
FDA Class 2 ·Cardiovascular

ODISSEY TISSUE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY

FDA 510(k)
FDA Class 2 ·Cardiovascular

T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303

FDA 510(k)
FDA Class 2 ·Cardiovascular

Masimo O3 Regional Oximeter System

FDA 510(k)
FDA Class 2 ·Cardiovascular

SoundBite Console, SoundBite Active Wire 18

FDA 510(k)
FDA Class 2 ·Cardiovascular

CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15

FDA 510(k)
FDA Class 2 ·Cardiovascular

PIONEER PLUS CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C

FDA 510(k)
FDA Class 2 ·Cardiovascular

FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)

FDA 510(k)
FDA Class 2 ·Cardiovascular

INPECTRA STO2 SPOT CHECK

FDA 510(k)
FDA Class 2 ·Cardiovascular

RVT CTO DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

RA-308 Excimer Laser System, Excimer Laser Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO THE CROSSER SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

CROSSER CTO Recanalization Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

ODI-Tech

FDA 510(k)
FDA Class 2 ·Cardiovascular

OCELOT SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

Intra.Ox™ 2.0 Handheld Tissue Oximeter

FDA 510(k)
FDA Class 2 ·Cardiovascular

PowerWire Radiofrequency Guidewire Kit

FDA 510(k)
FDA Class 2 ·Cardiovascular