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

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

NA

FDA UDI

MEDTRONIC, INC.·00885074153452·CUSTOM PACK CB4649R1SUPPORT SH

QUADROX-i

FDA UDI

Maquet Cardiopulmonary AG·04037691782072·

NX19 Oxygenator; left-side outlet port

FDA UDI

Terumo Cardiovascular Systems Corporation·00699753450998·

NA

FDA UDI

MEDTRONIC, INC.·00643169842922·CUSTOM PACK CB9L71R WILSON FP

QUADROX-i

FDA UDI

Maquet Cardiopulmonary AG·04037691526539·