| SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR (K031223) | Dideco S.P.A. | 2003-05-02 |
| VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING (K023381) | Gish Biomedical, Inc. | 2003-03-31 |
| QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 (K030264) | Jostra AG | 2003-02-26 |
| INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY (K022450) | Dideco S.P.A. | 2002-10-22 |
| CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR (K022115) | Terumo Corp. | 2002-09-27 |
| SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 (K013038) | Polystan A/S | 2002-08-14 |
| APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (K020997) | Dideco S.P.A. | 2002-04-04 |
| D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR (K020351) | Dideco S.P.A. | 2002-02-26 |
| APEX ADULT HOLLOWE FIBER OXYGENATOR (K014080) | Dideco S.P.A. | 2002-01-08 |
| D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER (K013915) | Dideco S.P.A. | 2001-12-27 |
| CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING (K010443) | Terumo Cardiovascular Systems Corp. | 2001-12-11 |
| COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR (K013480) | Cobe Cardiovascular, Inc. | 2001-11-16 |
| MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR (K004001) | Dideco | 2001-10-04 |
| DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR (K010478) | Dideco | 2001-09-27 |
| SAFE MINI (K980974) | Polystan A/S | 2000-10-13 |
| X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR (K993772) | Terumo Medical Corp. | 2000-06-05 |
| LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 (K001021) | Dideco S.P.A. | 2000-04-25 |
| COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR (K000255) | Cobe Cardiovascular, Inc. | 2000-04-25 |
| AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 (K000430) | Medtronic Vascular | 2000-02-25 |
| LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR (K991737) | Dideco S.P.A. | 2000-02-17 |
| MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE (K990103) | Sorin Biomedical, Inc. | 1999-11-05 |
| COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR (K991452) | Cobe Cardiovascular, Inc. | 1999-10-07 |
| HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 (K992559) | Jostra Bentley | 1999-09-20 |
| AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) (K992910) | Medtronic Vascular | 1999-09-15 |
| MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0 (K984271) | Medtronic Vascular | 1999-03-09 |
| COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR (K974812) | Cobe Cardiovascular, Inc. | 1998-06-01 |
| AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE (K973760) | Avecor Cardiovascular, Inc. | 1998-02-18 |
| COBE OXYGENATOR PRODUCTS (K974085) | Cobe Cardiovascular, Inc. | 1998-01-27 |
| COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR (K963518) | Cobe Cardiovascular, Inc. | 1997-12-08 |
| LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR (K971877) | Dideco S.P.A. | 1997-10-08 |
| COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS (K964043) | Cobe Cardiovascular, Inc. | 1997-09-29 |
| CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE (K961734) | Terumo Medical Corp. | 1997-07-07 |
| CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR (K970463) | Terumo Medical Corp. | 1997-05-06 |
| BIOCOR 200 HIGH PERFORMANCEOXYGENATOR (K964967) | Minntech Corp. | 1997-03-06 |
| SAFE MICRO (K953976) | Polystan A/S | 1997-02-04 |
| MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER (K962641) | Medtronic Vascular | 1996-12-16 |
| GISH RELIANCE OXYGENATOR (MODEL HFO) (K961530) | Gish Biomedical, Inc. | 1996-12-05 |
| BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR (K954850) | C.R. Bard, Inc. | 1996-10-30 |
| CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR (K960074) | Terumo Medical Corp. | 1996-10-16 |
| CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR (K962667) | Terumo Medical Corp. | 1996-10-07 |
| CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR (K961000) | Terumo Medical Corp. | 1996-10-02 |
| LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR (K953835) | Dideco S.R.L. | 1996-03-15 |
| SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS (K951247) | Baxter Healthcare Corp | 1995-11-02 |
| MAXIMA PLUS HOLLOW FIBER OXYGENATOR (K941473) | Medtronic Vascular | 1995-06-21 |
| SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION (K941653) | 3M Health Care, Sarns | 1994-08-24 |
| UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT (K941225) | Baxter Healthcare Corp | 1994-08-16 |
| WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR (K934292) | Minntech Corp. | 1994-07-26 |
| PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS (K931444) | Sorin Biomedica, Fiat, USA, Inc. | 1994-05-27 |
| MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE (K933586) | Medtronic Vascular | 1994-02-07 |
| AFFINITY HOLLOW FIBER OXYGENATOR (K932252) | Avecor Cardiovascular, Inc. | 1993-11-19 |
| COBE CMS-FS MEMBRANE OXYGENATOR (K926467) | Cobe Cardiovascular, Inc. | 1993-11-09 |
| CAPIOX SX HOLLOW FIBER OXYGENATOR (K922799) | Terumo Medical Corp. | 1993-09-02 |
| INTERSEPT FILTERED CARDIOTOMY RESERVOIR (K926226) | Medtronic Vascular | 1993-06-22 |
| SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R. (K925076) | 3M Health Care, Sarns | 1993-06-07 |
| SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR (K925075) | 3M Health Care, Sarns | 1993-06-07 |
| COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR (K923272) | Cobe Laboratories, Inc. | 1993-05-11 |
| MAXIMA PLUS HOLLOW FIBER OXYGENATOR (K925626) | Medtronic Vascular | 1993-02-05 |
| SORIN MONOLYRH INTEGRATED MEMBRANE LUNG (K922933) | Sorin Biomedica, Fiat, USA, Inc. | 1992-11-30 |
| MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS (K920889) | Medtronic Vascular | 1992-09-15 |
| SAFE II (K912082) | Polystan A/S | 1991-12-04 |
| SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY (K912079) | 3M Health Care, Sarns | 1991-10-23 |
| SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER (K912920) | 3M Health Care, Ltd. | 1991-09-25 |
| MINIMAX OXYGENATION SYSTEM (K912655) | Medtronic Vascular | 1991-09-13 |
| MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR (K897068) | Medtronic Vascular | 1991-08-28 |
| SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION (K912078) | 3M Health Care, Sarns | 1991-08-20 |
| NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS (K911227) | 3M Health Care, Sarns | 1991-05-29 |
| DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD (K910107) | Baxter Healthcare Corp | 1991-04-10 |
| SARNS MEMBRANE OXGENATOR PART NUMBER 9443 (K903436) | 3M Health Care, Sarns | 1990-10-19 |
| (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 (K901253) | Bio Medicus, Inc. | 1990-09-05 |
| SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. (K901624) | Shiley, Inc. | 1990-07-03 |
| PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR (K901250) | Shiley, Inc. | 1990-06-11 |
| PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR (K901249) | Shiley, Inc. | 1990-06-11 |
| UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF (K894826) | Bentley Laboratories, Inc. | 1990-02-28 |
| CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE (K896978) | Medtronic Vascular | 1990-02-28 |
| SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461 (K896671) | 3M Company | 1990-02-14 |
| CARDIOPULMONARY SUPPORT (CPS) SYSTEM (K892664) | Bard Cardiosurgery Div | 1990-02-13 |
| SAFE-1 (K893704) | Polystan C/O Vitalcor, Inc. | 1989-12-22 |
| SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380 (K895632) | 3M Company | 1989-12-12 |
| CLOSED CHEST SUPPORT CIRCUIT (K893207) | Medtronic Blood Systems, Inc. | 1989-12-12 |
| SARNS INGANT MEMBRANE OXYGENATOR (K895393) | 3M Company | 1989-12-04 |
| BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES (K892641) | Bard Cardiosurgery Div | 1989-11-01 |
| WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR (K894970) | Minntech Corp. | 1989-11-01 |
| SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR (K894630) | Shiley, Inc. | 1989-10-20 |
| SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II (K894103) | Scimed Life Systems, Inc. | 1989-09-21 |
| EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE (K891687) | Medtronic Blood Systems, Inc. | 1989-05-31 |
| MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. (K891230) | Medtronic Blood Systems, Inc. | 1989-05-19 |
| SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV (K890808) | 3M Company | 1989-05-01 |
| MEMBRANE OXYGENATOR (K882892) | Baxter Bentley Laboratories, Inc. | 1988-09-27 |
| SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II (K883054) | Scimed Life Systems, Inc. | 1988-09-26 |
| SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A (K883053) | Scimed Life Systems, Inc. | 1988-09-26 |
| COBE CML3 (K880021) | Cobe Laboratories, Inc. | 1988-04-01 |
| INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (K874841) | Bentley Laboratories, Inc. | 1988-02-02 |
| INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (K873923) | American Bentley | 1987-11-06 |
| WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR (K872107) | Minntech Corp. | 1987-08-28 |
| OXYGENATOR MODEL NO. BENTLEY 5 PLUS (K872133) | American Bentley | 1987-08-24 |
| BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600 (K864235) | C.R. Bard, Inc. | 1987-01-02 |
| SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO (K863476) | Scimed Life Systems, Inc. | 1986-11-25 |
| MODIFIED SARNS OXYGENATOR SYSTEM (K863515) | 3M Health Care, Sarns | 1986-11-18 |
| OXYGENATOR MODEL NO. BENTLEY-10 PLUS (K863249) | American Bentley | 1986-10-20 |
| HEPARIN-COATED EXTRACORPOREAL CIRCUITS (K861641) | American Bentley | 1986-09-29 |