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

MF-272/300-HHz-DT

Basic UDI-DI

EU MDD · Eu Md Class 2b ·MED-Fibers, Inc.·1 device

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·IntellaNav ST Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II HTD Temperature Ablation Catheter, a

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI

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·

NA

FDA UDI

Maquet Cardiopulmonary AG·04037691725062·

Quadrox-iD

FDA UDI

Maquet Cardiopulmonary AG·04058863154435·QUADROX-iD Pediatric with BIOLINE Coating

NX19 East Sub-Assembly-Japan Only, Export Only

FDA UDI

Terumo Cardiovascular Systems Corporation·00699753450905·

QUADROX-i

FDA UDI

Maquet Cardiopulmonary AG·04037691843346·

NX19 Oxygenator; right-side outlet port

FDA UDI

Terumo Cardiovascular Systems Corporation·00699753450981·

INSPIRE

FDA UDI

SORIN GROUP ITALIA SRL·08033178112420·

NA

FDA UDI

MEDTRONIC, INC.·00643169878877·CUSTOM PACK CB5E20R HF STPCOCK