EOS PMP, EOS PMP Integrated

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDOS HILITE INFANT OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISP. TOUGY-BORST TYPE ADAPTOR W/PORT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

BLOOD OXYGENATOR 5070

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFFINITY HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)

FDA 510(k)

FDA Class 2 ·Cardiovascular

JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030

FDA 510(k)

FDA Class 2 ·Cardiovascular

BUILT-IN TEMPERATURE MONITORING

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBE CML3

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W

FDA 510(k)

FDA Class 2 ·Cardiovascular