OXY-1 System

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CentriMag Pre-connected Pack

FDA 510(k)

FDA Class 2 ·Cardiovascular

MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity NT Oxygenator with Cortiva BioActive Surface

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity Fusion™ Oxygenator System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAXIMA PLUS HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERSEPT FILTERED CARDIOTOMY RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0

FDA 510(k)

FDA Class 2 ·Cardiovascular