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

Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

OXYGENATOR MODEL NO. BENTLEY-10 PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

OXYGENATOR MODEL NO. BENTLEY 5 PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Oxygenator, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Oxygenator, Cardiopulmonary Bypass

Kidney Perfusion Kit

FDA classification

FDA Class 2 ·Kidney Perfusion Kit

Parenteral Administration Kit

FDA classification

FDA Class 2 ·Parenteral Administration Kit