| Essenz HLM, Essenz ILBM (K232291) | Livanova Deutschland, GmbH | 2023-08-24 |
| Terumo Advanced Perfusion System 1 (K221895) | Terumo Cardiovascular Systems Corporation | 2023-04-18 |
| Essenz HLM (K221373) | Livanova Deutschland, GmbH | 2023-03-09 |
| Stockert S5 System (K210130) | Livanova Deutschland, GmbH | 2021-04-05 |
| Century Perfusion System (K202125) | Century Hlm, LLC | 2021-03-07 |
| Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (K190282) | Spectrum Medical , Ltd. | 2019-05-24 |
| Quantum Pump Console (K173834) | Spectrum Medical , Ltd. | 2018-05-25 |
| Advanced Perfusion System 1 (K172220) | Terumo Cardiovascular Systems Corporation | 2017-08-17 |
| Advanced Perfusion System 1 (K163531) | Terumo Cardiovascular Systems Corporation | 2017-06-07 |
| Advanced Perfusion System 1 (K153376) | Terumo Cardiovascular Systems Corporation | 2015-12-16 |
| Advanced Perfusion System 1 (K151349) | Terumo Cardiovascular Systems Corporation | 2015-08-27 |
| CARDIOHELP SYSTEM (K133598) | Maquet Cardiopulmonary, AG | 2014-05-21 |
| ADVANCED PERFUSION SYSTEM 1 (K131041) | Terumo Cardiovascular Systems Corp. | 2014-02-20 |
| CARDIOHELP SYSTEM (K102726) | Maquet Cardiopulmonary, AG | 2011-04-04 |
| SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE (K103762) | Sorin Group Deutschland GmbH | 2011-01-20 |
| SORIN C5 SYSTEM MODEL 58-00-00 (K093882) | Sorin Group Deutschland GmbH | 2010-01-15 |
| SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM (K092463) | Sorin Group Deutschland GmbH | 2009-11-05 |
| LIFEBRIDGE B2T, MODEL 7001 (K090006) | Lifebridge Medizintechnik AG | 2009-10-15 |
| AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 (K091007) | Sorin Group Deutschland GmbH | 2009-07-02 |
| STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER (K080832) | Sorin Group Deutschland GmbH | 2008-07-30 |
| MODIFICATION TO: STOCKERT S5 SYSTEM (K071318) | Sorin Group Deutschland GmbH | 2007-07-06 |
| PERFORMER CBP SYSTEM (K070213) | Rand S.R.L. | 2007-03-21 |
| MODIFICATION TO STOCKERT S5 SYSTEM (K062396) | Sorin Group Deutschland GmbH | 2006-09-28 |
| STOCKERT S5 SYSTEM (K060053) | Sorin Group Deutschland GmbH | 2006-06-02 |
| MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB (K052555) | Rand S.R.L. | 2006-03-15 |
| ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH (K022947) | Terumo Cardiovascular Systems Corp. | 2003-03-20 |
| MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 (K030141) | Cardiovention, Inc. | 2003-02-26 |
| CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 (K021694) | Cardiovention, Inc. | 2003-01-08 |
| STOCKERT CENTRIFUGAL PUMP CONSOLE (K020571) | Stockert Instrumente GmbH | 2002-09-23 |
| SIII ALARM AMPLIFIER (K011088) | Stockert Instrumente GmbH | 2001-05-02 |
| S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 (K002116) | Medical Device Consultants, Inc. | 2000-08-09 |
| STOCKERT COMPACT SYSTEM VERSION 2.0 (K002118) | Stoeckert Instrumente | 2000-08-09 |
| STOCKERT COMPACT SYSTEM (K982014) | Stoeckert Instrumente | 1998-09-04 |
| AFFINITY BLOOD PUMP SYSTEM (K964017) | Avecor Cardiovascular, Inc. | 1997-08-05 |
| JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM (K943803) | Janus Biomedical, Inc. | 1996-01-30 |
| STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE (K950990) | Stoeckert Instrumente | 1996-01-19 |
| SORIN BLOOD CARDIOPLEGIA CONSOLE (K942582) | Sorin Biomedical, Inc. | 1995-01-27 |
| SARNS 8000 MODULAR PERFUSION SYSTEM (K915183) | 3M Health Care, Sarns | 1992-07-08 |
| SARNS 9000 HEART-LUNG CONSOLE (K871131) | 3M Health Care, Sarns | 1987-05-21 |
| ONGUARD 1000, CATALOG #043611-000 & 043611-001 (K870976) | Cobe Laboratories, Inc. | 1987-05-06 |
| STOCKERT-SHILEY CAPS BATTERY MODULE (K863960) | Shiley, Inc. | 1986-12-11 |
| STOCKERT-SHILEY CAPS HLM INTERFACE (K863541) | Shiley, Inc. | 1986-11-18 |
| STOCKERT-SHILEY CAPS TIMER MODULE (K862973) | Shiley, Inc. | 1986-10-01 |
| SARNS PORTABLE POWER MODULE (K861388) | 3M Health Care, Sarns | 1986-06-23 |
| CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE (K851615) | Centrimed Corp. | 1985-06-19 |
| CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY (K851614) | Centrimed Corp. | 1985-06-19 |
| COBE EMERGENCY POWER SOURCE 43610-000 (K842138) | Cobe Laboratories, Inc. | 1984-08-03 |
| GAMBRO PUMP CONSOLE CSL (K822068) | Gambro, Inc. | 1982-08-24 |
| POLYSTAN HEART LUNG MACHINE SYS (K813034) | Advocacy International, Ltd. | 1981-11-27 |
| SARNS 7000 MONITOR MODULE (K801097) | 3M Health Care, Sarns | 1980-05-20 |
| SARNES HELP (K772001) | 3M Health Care, Sarns | 1977-11-02 |
| CONSOLE, MOBILE FOR 3 PUMPS W/MASTS (K770002) | Cobe Laboratories, Inc. | 1977-03-07 |