| XTRA Collection sets; XTRA Sequestration set X (K241236) | Sorin Group Italia S.R.L. | 2024-08-16 |
| Aventus Clot Management System (K240426) | Inquis Medical | 2024-05-14 |
| XTRA Autotransfusion System (with XTRA Bowl sets) (K240584) | Sorin Group Italia S.R.L. | 2024-04-29 |
| FlowSaver Blood Return System (80-101) (K231782) | Inari Medical, Inc. | 2023-07-14 |
| FlowSaver Blood Return System (K221483) | Inari Medical, Inc. | 2023-02-17 |
| Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (K221722) | Haemonetics Corporation | 2022-11-15 |
| Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain (K201305) | Atrium Medical Corporation | 2021-09-03 |
| Hemafuse System (K210862) | Sisu Global Health | 2021-07-29 |
| FlowSaver Blood Filter (K210176) | Inari Medical | 2021-07-22 |
| CATSmart, Automated Blood Processing Autotransfusion System (K210089) | Fresenius Kabi AG | 2021-02-11 |
| ProCell Surgical Sponge-Blood Recovery Unit (K193361) | Procell Surgical, Inc. | 2020-06-01 |
| CATSmart (K192368) | Fresenius Kabi AG | 2019-09-27 |
| CATSmart (K180831) | Fresenius Kabi AG | 2018-12-10 |
| autoLog IQ Autotransfusion System (K181954) | Medtronic Perfusion Systems | 2018-08-22 |
| Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (K162423) | Haemonetics Corporation | 2017-01-03 |
| CATSmart (K160735) | Fresenius Kabi AG | 2016-09-16 |
| Haemonetics Cell Saver Elite Autotransfusion System (K160197) | Haemonetics Corporation | 2016-05-24 |
| PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM (K140205) | Teleflexmedical, Inc. | 2014-10-23 |
| PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM (K140197) | Teleflexmedical, Inc. | 2014-10-21 |
| XTRA (K131553) | Sorin Group Deutschland GmbH | 2014-03-21 |
| PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (K130043) | Teleflexmedical, Inc. | 2013-02-12 |
| PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM (K120953) | Tlelflex Medical, Inc. | 2012-12-10 |
| ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM (K122262) | Haemonetics Corp. | 2012-10-25 |
| CELL SAVER ELITE (K120586) | Haemonetics Corp. | 2012-05-22 |
| XTRA (K112245) | Sorin Group Italia S.R.L. | 2011-09-06 |
| XVAC (K110782) | Sorin Group Italia S.R.L. | 2011-04-07 |
| HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM (K101907) | Haemonetics Corp. | 2010-12-03 |
| PREASSEMBLED SURGICAL WASH SET (K103202) | Sorin Group Italia S.R.L. | 2010-11-23 |
| XTRA AUTOTRANSFUSION SYSTEM (K101586) | Sorin Group Italia S.R.L. | 2010-10-05 |
| AUTOLOG AUTOTRANSFUSION SYSTEM (K093535) | Medtronic, Inc. | 2010-03-22 |
| PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C (K082923) | Life-Tech, Inc. | 2008-10-24 |
| CYTORI CELUTION CELL CONCENTRATION DEVICE (K060482) | Cytori Therapeutics, Inc. | 2006-09-28 |
| HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) (K053000) | Haemonetics Corp. | 2005-11-21 |
| HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (K043127) | Haemonetics Corp. | 2005-01-04 |
| EXPRESS AND OASIS CHEST DRAIN (K043140) | Atrium Medical Corp. | 2004-12-08 |
| HEMOVAC BLOOD REINFUSION SYSTEM (K041525) | Zimmer, Inc. | 2004-10-14 |
| S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (K031554) | Genzyme Biosurgery | 2003-07-25 |
| PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM (K022167) | Pall Corp. | 2003-03-07 |
| SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 (K024097) | Summit Medical , Ltd. | 2003-02-14 |
| SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 (K022489) | Summit Medical , Ltd. | 2002-10-09 |
| DIDECO ELECTA (K020647) | Dideco S.P.A. | 2002-09-05 |
| ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000 (K022348) | Interpore Cross Intl. | 2002-08-15 |
| ACCESS SEQUESTRATION SYSTEM (K012406) | Interpore Cross Intl. | 2002-03-26 |
| AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM (K014187) | Boehringer Laboratories | 2002-02-06 |
| HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM (K014083) | Haemonetics Corp. | 2002-01-08 |
| FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW (K012178) | Fresenius Hemotechnology, Inc. | 2001-07-23 |
| HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER (K993581) | Haemonetics Corp. | 1999-11-18 |
| ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM (K992723) | Transfusion Technologies Corp. | 1999-10-18 |
| COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION (K991986) | Cobe Cardiovascular, Inc. | 1999-09-09 |
| SMARTCELL PROCESSING SYSTEM (K983022) | Harvest Technologies, LLC | 1999-04-02 |
| ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM (K982660) | Transfusion Technologies Corp. | 1999-03-30 |
| C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE (K984233) | Fresenius Hemotechnology, Inc. | 1999-02-01 |
| RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 (K982712) | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-12-18 |
| AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) (K982650) | Dideco S.P.A. | 1998-12-16 |
| BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX (K982241) | Duxbury Scientific, Inc. | 1998-11-30 |
| MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) (K982755) | Medtronic Blood Management | 1998-08-20 |
| AUTOTRANSFUSION APPARTUS (AUTOLOG) (K972894) | Medtronic Blood Management | 1998-04-27 |
| COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET (K974897) | Cobe Cardiovascular, Inc. | 1998-03-31 |
| CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE (K963758) | Sorin Biomedical, Inc. | 1998-02-20 |
| DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS (K963759) | Sorin Biomedical, Inc. | 1998-02-20 |
| STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) (K970714) | Stryker Instruments | 1997-12-16 |
| ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO (K970857) | Davis & Geck, Inc. | 1997-11-05 |
| C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 (K973378) | Fresenius USA, Inc. | 1997-11-03 |
| STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM (K973627) | Cobe Cardiovascular, Inc. | 1997-11-03 |
| C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET (K971274) | Fresenius AG | 1997-06-13 |
| PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (K963850) | Deknatel, Inc. | 1997-04-22 |
| ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM (K962475) | Transfusion Technologies Corp. | 1997-02-20 |
| COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP) (K962689) | Cobe Cardiovascular, Inc. | 1997-01-28 |
| DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG (K964070) | Deknatel, Inc. | 1996-12-31 |
| HAEMOCELL SYSTEM 350 OR S350 (K960734) | Haemocell Plc | 1996-12-10 |
| PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) (K963098) | Deknatel, Inc. | 1996-11-08 |
| C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM (K960006) | Fresenius AG | 1996-07-31 |
| AUTOVAC BP SYSTE, 2000 SERIES (K955010) | Boehringer Laboratories | 1996-06-20 |
| LEVEL 1 BLOOD STREAM RECOVERY SYSTEM (K942844) | Level 1 Technologies, Inc. | 1996-04-26 |
| BETATRANS I AND II (K951592) | Duxbury Scientific, Inc. | 1996-03-04 |
| CARACELL (K953118) | Medtronic Vascular | 1996-02-23 |
| STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) (K952224) | Stryker Instruments | 1995-11-17 |
| BOEHRINGER AUTOVAC(R) 7900 SERIES (K945775) | Boehringer Laboratories | 1995-10-19 |
| AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS (K944232) | Haemonetics Corp. | 1995-07-20 |
| ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT (K942791) | Sherwood Medical Co. | 1995-05-10 |
| DIDECO VACUUM PUMP (K936220) | Dideco | 1995-01-27 |
| DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM (K940519) | Dideco | 1995-01-19 |
| DAVOL ATS (K931899) | Davol, Inc. | 1994-11-15 |
| PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F (K926338) | Deknatel, Inc. | 1994-07-26 |
| AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S (K932093) | Boehringer Laboratories | 1994-07-06 |
| PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM (K933960) | Cobe Cardiovascular, Inc. | 1994-06-10 |
| AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER (K940678) | Baxter Healthcare Corp | 1994-04-15 |
| CELL SAVER 5 SYSTEM (K932890) | Haemonetics Corp. | 1994-01-05 |
| BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM (K933625) | Cobe Cardiovascular, Inc. | 1993-12-29 |
| DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT (K931552) | Davol, Inc. | 1993-10-08 |
| BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT (K931106) | Deknatel, Inc. | 1993-10-06 |
| IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI (K925827) | Impra, Inc. | 1993-07-29 |
| AUTOTRANSFUSION SUCTION SET (K920618) | Lifestream Int'L, Inc. | 1993-03-12 |
| SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM (K913247) | Solco Basle, Inc. | 1993-02-25 |
| SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM (K913177) | Solco Basle, Inc. | 1993-02-25 |
| MAT MEMBRANE AUTOTRANSFUSION SYSTEM (K915130) | Estracorporeal, Inc. | 1993-02-22 |
| AUTOVAC 7900 SERIES (K924894) | Boehringer Laboratories | 1993-02-05 |
| HEMOVAC AUTOTRANSFUSION SYSTEM (K920273) | Zimmer Patient Care Division | 1993-01-28 |
| DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM (K914119) | Davol, Inc. | 1992-12-03 |
| AUTOLOGOUS BLOOD COLLECTION SET (K923016) | Advanced Haemotechnologies | 1992-11-23 |