| Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (K252541) | Spectrum Medical S.R.L. | 2026-03-12 |
| Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) (K240908) | Spectrum Medical , Ltd. | 2025-07-08 |
| VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) (K250150) | Sorin Group Italia S.R.L. | 2025-05-30 |
| MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated (K240190) | Medtronic | 2024-02-23 |
| Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) (K223879) | Quara S.R.L. | 2023-04-13 |
| Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger (K220110) | Qura S.R.L | 2022-05-06 |
| Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger (K212688) | Qura S.R.L | 2022-01-10 |
| MPS 3 ND Myocardial Protection System (K201984) | Quest Medical, Inc. | 2020-11-20 |
| MPS 3 Myocardial Protection System (K200438) | Quest Medical, Inc. | 2020-06-19 |
| MPS2 Myocardial Protection System Console (K173716) | Quest Medical, Inc. | 2018-10-01 |
| MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) (K162774) | Medtronic, Inc. | 2017-02-10 |
| MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge (K162958) | Medtronic, Inc. | 2017-02-01 |
| PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 (K090555) | Maquet Cardiopulmonary, AG | 2009-12-23 |
| GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING (K081838) | Gish Biomedical, Inc. | 2009-01-26 |
| PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 (K072583) | Maquet Cardiopulmonary, AG | 2008-04-04 |
| MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 (K041979) | Quest Medical, Inc. | 2004-09-02 |
| VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING (K040355) | Gish Biomedical, Inc. | 2004-03-15 |
| CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 (K032068) | Cardiovention, Inc. | 2003-08-22 |
| SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM (K021830) | Cobe Cardiovascular, Inc. | 2002-07-02 |
| VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER (K020106) | Gish Biomedical, Inc. | 2002-04-10 |
| MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM (K012898) | Cobe Cardiovascular, Inc. | 2001-09-17 |
| COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS (K000977) | Olson Medical Sales, Inc. | 2001-03-23 |
| CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B (K003724) | Medtronic Vascular | 2000-12-21 |
| ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER (K991137) | Minntech Corp. | 2000-06-08 |
| CAPIOX CARDIOPLEGIA (K982467) | Terumo Medical Corp. | 1999-06-23 |
| CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) (K973475) | Medtronic Vascular | 1997-11-20 |
| VISION CARDIOPLEGIA DELIVERY SYSTEM (K964571) | Lifestream Int'L, Inc. | 1997-08-08 |
| S3 CARDIOPLEGIA CONTROL (K962320) | Stoeckert Instrumente | 1997-01-10 |
| MYOCARDIAL PROTECTION SYSTEM (K953838) | Quest Medical, Inc. | 1996-03-06 |
| SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS (K944219) | Gish Biomedical, Inc. | 1995-06-30 |
| HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA (K944267) | Cobe Cardiovascular, Inc. | 1995-04-28 |
| ELECTROMEDICS BLOOD HEAT EXCHANGER (K934355) | Electromedics, Inc. | 1993-12-03 |
| ROTATOR;MALE-MALE, MALE-FEMALE (K932251) | Merit Medical Systems, Inc. | 1993-08-05 |
| HE-30 GOLD (K931967) | Bentley Laboratories, Inc. | 1993-07-13 |
| BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS (K925369) | Sorin Biomedica, Fiat, USA, Inc. | 1993-03-26 |
| CONDUCER HEAT EXCHANGER (K923311) | 3M Health Care, Sarns | 1992-09-18 |
| LANCASTER COOLING JACKET, CAT. CODE #13500/13501 (K913077) | Dlp, Inc. | 1992-01-09 |
| CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES (K913691) | Gish Biomedical, Inc. | 1991-12-18 |
| MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF (K914742) | Medtronic Vascular | 1991-12-04 |
| MYOCARDIAL PROTECTION SYSTEM (K905500) | Medtronic Vascular | 1991-06-10 |
| BCD ADVANCED (K910923) | Shiley, Inc. | 1991-04-09 |
| TOPICAL COOLING PAD, MODEL 7000 (K905568) | Daily Medical Products, Inc. | 1991-01-23 |
| SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM (K904171) | Scimed | 1990-12-06 |
| SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM (K896807) | Gish Biomedical, Inc. | 1990-07-31 |
| EXTRACORPOREAL HEAT EXCHANGER HE SERIES (K896020) | Gish Biomedical, Inc. | 1990-05-17 |
| MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU (K900640) | 3M Company | 1990-04-20 |
| SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM) (K897039) | 3M Company | 1990-03-16 |
| SCIMED ECMOTHERM(TM) HEAT EXCHANGER (K884560) | Scimed Life Systems, Inc. | 1989-04-03 |
| SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM (K883071) | 3M Health Care, Sarns | 1988-12-05 |
| INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM (K883439) | Medtronic Blood Systems, Inc. | 1988-10-13 |
| BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 (K883330) | Shiley, Inc. | 1988-09-26 |
| BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10 (K883331) | Shiley, Inc. | 1988-09-26 |
| MAST FOR BASIC HEATER-COOLER UNIT 16-09-00 (K883332) | Shiley, Inc. | 1988-09-26 |
| SHILEY BCD PLUS HEAT EXCHANGER (K880663) | Shiley, Inc. | 1988-05-11 |
| SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS (K880451) | Scimed Life Systems, Inc. | 1988-04-28 |
| ELECTROMEDICS D1079E (K873561) | Electromedics, Inc. | 1987-11-05 |
| CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 (K870804) | American Bentley | 1987-09-01 |
| CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS (K871774) | Gish Biomedical, Inc. | 1987-08-03 |
| CPS-3000 CARDIOPLEGIA RESERVOIR (K861102) | Gish Biomedical, Inc. | 1986-05-28 |
| STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL (K860920) | Shiley, Inc. | 1986-05-21 |
| CARDIO-COOL (K860523) | Bio-Vascular, Inc. | 1986-04-29 |
| NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 (K853791) | Norton Performance Plastics Corp. | 1985-12-09 |
| SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM (K853516) | 3M Health Care, Sarns | 1985-11-14 |
| MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD (K853410) | Intermedics, Inc. | 1985-10-11 |
| BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV) (K852780) | Shiley, Inc. | 1985-09-30 |
| PATIENT MONITOR MODEL RM-300 (K850794) | Honeywell, Inc. | 1985-04-18 |
| MYOCARDIAL INSULATOR (K843983) | Norton Texas Medical Products | 1984-12-27 |
| CARDIOPLEGIA HEAT EXCHANGER HOLDER (K840256) | American Bentley | 1984-02-17 |
| CARDIOPLEGIA HEAT EXCHANGER HE-100 (K840045) | American Bentley | 1984-02-13 |
| LAL TEST RELEASE & BONCHEK CAR/JACKET (K833555) | Shiley, Inc. | 1984-02-04 |
| CARDIOPLEGIA SYSTEM CCS-XXX SERIES (K833662) | Gish Biomedical, Inc. | 1983-12-29 |
| HYPOTHERMIC MYCARDIAL PROTECTION DEV (K832417) | 3M Health Care, Sarns | 1983-10-20 |
| BLOOD CARDIOPLEGIA STAINLESS STEEL COOL (K831157) | American Bentley | 1983-05-09 |
| CLEAR CARDIOPLEJIA DELIVERY SYSTEM (K823451) | 3M Health Care, Sarns | 1983-01-14 |
| JACKET & SET (K823533) | Shiley, Inc. | 1982-12-30 |
| D6ZO DISPOSABLE HEAT EXCHANGER (K813264) | Electromedics, Inc. | 1982-07-06 |
| COBE HEAT EXCHANGER RESERVOIR MODULE (K812093) | Cobe Laboratories, Inc. | 1981-08-13 |
| BRONCHEK-SHILEY CARDIAC JACKET & BSC J (K811204) | Shiley, Inc. | 1981-05-21 |
| CARDIOPLEGIC SETS (K802545) | Texas Medical Products, Inc. | 1981-01-16 |
| BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL. (K802879) | Shiley, Inc. | 1980-12-19 |
| CARDIOPLEGIA COOLING SYST. CCAS-2 (K802848) | Bentley Laboratories, Inc. | 1980-12-11 |
| TOPICAL COOLING DEV. TCD. #27-999 (K800717) | Cobe Laboratories, Inc. | 1980-04-16 |
| CARDIOPLEGIA DELIVERY SYSTEM (K800377) | 3M Health Care, Sarns | 1980-03-19 |
| MINIPRIME HYPOTHERMIC HEAT EXCHANGER (K791430) | Travenol Laboratories, S.A. | 1979-08-28 |
| HEAT EXCHANGER COIL (K790756) | Delta Medical Industries | 1979-06-11 |
| PAD, COOLING #27-999 (K781764) | Cobe Laboratories, Inc. | 1978-12-04 |
| HEAT EXCHANGER, FHX-14 (K781210) | Delta Medical Industries | 1978-10-10 |
| HEAT EXCHANGER, DISP., OMNITHERM (K772117) | Scimed Life Systems, Inc. | 1978-03-02 |
| PACING KIT, TRANSMYOCARDIAL (K770017) | Electro-Catheter Corp. | 1977-01-14 |
| PACING KIT, ELECATH TRANSTHORACIC (K770016) | Electro-Catheter Corp. | 1977-01-14 |
| PACING KIT, SEMI-FLOATING (K770018) | Electro-Catheter Corp. | 1977-01-14 |