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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: dtz Decision Date From: 1%2F1%2F1965 Decision Date To: 1%2F1%2F2015
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x-coated capiox sx18 and sx25 hollow fiber oxygenator with/ without detachable hardshell reservoir TERUMO MEDICAL CORP. K993772 06/05/2000
wm. harvey parallel plate membrane blood C.R. BARD, INC. K831705 07/18/1983
wm. harvey h-1300 infant/pediatric blood C.R. BARD, INC. K821477 11/01/1982
william harvey hybid oxygenator h-1700 C.R. BARD, INC. K853080 10/11/1985
william harvey hf5000 membrane oxygenator MINNTECH CORP. K934292 07/26/1994
william harvey hf5000 membrane oxygenator MINNTECH CORP. K894970 11/01/1989
william harvey hf5000 membrane oxygenator MINNTECH CORP. K872107 08/28/1987
william harvey h-1700 adult blood oxyg- C.R. BARD, INC. K831122 05/25/1983
william harvey h-1500 blood oxygenator C.R. BARD, INC. K792039 10/30/1979
vision hollow fiber oxygenator with ha coating GISH BIOMEDICAL, INC. K080708 02/02/2009
vision hollow fiber oxygenator with guardian coating GISH BIOMEDICAL, INC. K023381 03/31/2003
variable prime cobe membrane lung COBE LABORATORIES, INC. K842908 02/01/1985
univox w/holders, models univox-hl, hlb, hlf BENTLEY LABORATORIES, INC. K894826 02/28/1990
univix gold membrane oxygenation module with duroflo ii heparin treatment BAXTER HEALTHCARE CORP. K941225 08/16/1994
tubular hollow fiber membrane AMERICAN BENTLEY K841476 08/03/1984
tmo total bypass membrane oxygenator-i TRAVENOL LABORATORIES, S.A. K760824 11/12/1976
thb 6000 hardshell bubble oxygenator TRAVENOL LABORATORIES, S.A. K803231 01/16/1981
terumo hollow fiber oxygenator TERUMO MEDICAL CORP. K812660 12/14/1981
terumo hollow fiber oxygenator TERUMO AMERICA, INC. K802970 01/22/1981
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 TERUMO CARDIOVASCULAR SYSTEMS CORP. K153140 12/02/2015
terumo capiox nx19 oxygenator with reservoir (east orientation), terumo capiox nx19 oxygenator with reservoir (west orientation), terumo capiox nx19 oxygenator (east orientation), terumo capiox nx19 oxygenator (west orientation) Terumo Cardiovascular Systems Corporation K180950 06/22/2018
terumo capiox nx19 oxygenator with reservoir (east orientation ), terumo capiox nx19 oxygenator with reservoir (west orientation ), terumo capiox nx19 oxygenator (east orientation ), terumo capiox nx19 oxygenator (west orientation) Terumo Cardiovascular Systems Corporation K172071 03/29/2018
terumo capiox fx15 and fx25 hollow fiber oxygenator/reservoir Terumo Cardiovascular Systems Corporation K140774 06/02/2014
terumo capiox fx15 advance oxygenator with integrated arterial filter and reservoir, terumo capiox fx25 advance oxygenator with integrated arterial filter and reservoir TERUMO CARDIOVASCULAR SYSTEMS CORPORATION K151791 11/19/2015
terumo capiox fx15 advance oxygenator with integrated arterial filter and hardshell reservoir Terumo Cardiovascular Systems Corporation K151389 10/20/2015
tandemlung oxygenator CARDIAC ASSIST, INC. K153295 02/26/2016
synthesis ph.i.s.i.o. adult membrane oxygenator with integrated areterial filter and hardshell venous/cariotomy reservoi SORIN GROUP ITALIA S.R.L. K073380 02/29/2008
synthesis mimesys adult membrane oxygenator DIDECO S.P.A. K031223 05/02/2003
spiralgold & spiraloxy hollow fiber oxygenators BAXTER HEALTHCARE CORP. K951247 11/02/1995
spiraflo blood oxygenators model bos-5s BENTLEY LABORATORIES, INC. K802720 12/16/1980
spiraflo blood oxygenators model bos-10s BENTLEY LABORATORIES, INC. K802719 12/16/1980
sorin monolyrh integrated membrane lung SORIN BIOMEDICA, FIAT, USA, INC. K922933 11/30/1992
shiley s-100a (adult) blood oxygenator SHILEY, INC. K810470 04/17/1981
shiley plexus(tm) adult hollow fiber oxygenator SHILEY, INC. K894630 10/20/1989
shiley plexus integral reservoir hollow fiber oxy. SHILEY, INC. K901624 07/03/1990
shiley m2000 membrane oxygenator SHILEY, INC. K833253 12/01/1983
scimed ultrox true membrane oxygen syst, ultrox ii SCIMED LIFE SYSTEMS, INC. K894103 09/21/1989
scimed ultrox true membrane oxy. ultrox i & ii SCIMED LIFE SYSTEMS, INC. K883054 09/26/1988
scimed membrane oxygenator, model 0600-2a SCIMED LIFE SYSTEMS, INC. K883053 09/26/1988
scimed membrane oxygenator system - ecmo SCIMED LIFE SYSTEMS, INC. K863476 11/25/1986
scimed ii-sm25 membrane oxygenator system SCIMED LIFE SYSTEMS, INC. K862918 09/23/1986
scimed ii membrane oxygenator system SCIMED LIFE SYSTEMS, INC. K843956 01/08/1985
sarns turbo membrane oxygenator modification 3M HEALTH CARE, SARNS K941653 08/24/1994
sarns turbo membrane oxygena. w/int. reservoir 3M HEALTH CARE, SARNS K925075 06/07/1993
sarns turbo membrane oxygena. w/int. cardiotomy r. 3M HEALTH CARE, SARNS K925076 06/07/1993
sarns smoc membrane oxy w/integrat card res,modify 3M HEALTH CARE, SARNS K912079 10/23/1991
sarns sm03 membrane oxygenator, modification 3M HEALTH CARE, SARNS K912078 08/20/1991
sarns sm03 membrane oxygenator w/ integrated reser 3M HEALTH CARE, LTD. K912920 09/25/1991
sarns oxygenator system 3M HEALTH CARE, SARNS K860539 04/29/1986
sarns membrane oxygenator w/integral reser. #9461 3M COMPANY K896671 02/14/1990
sarns membrane oxygenator w/integral cardio reserv 3M COMPANY K890808 05/01/1989
sarns membrane oxygenator w/integral cadio. 16380 3M COMPANY K895632 12/12/1989
sarns membrane oxgenator part number 9443 3M HEALTH CARE, SARNS K903436 10/19/1990
sarns ingant membrane oxygenator 3M COMPANY K895393 12/04/1989
safe-1 POLYSTAN C/O VITALCOR, INC. K893704 12/22/1989
safe mini POLYSTAN A/S K980974 10/13/2000
safe micro POLYSTAN A/S K953976 02/04/1997
safe maxi hollow fiber oxygenator, model 016010 POLYSTAN A/S K013038 08/14/2002
safe ii POLYSTAN A/S K912082 12/04/1991
rapido cut-away bleedback control valve (bbcv), model 7568 GUIDANT CORPORATION K031903 03/03/2004
quantum perfusion blood oxygenator with integrated af and sensor vt75-c1u, quantum perfusion blood oxygenator with integrated af vt75-c2u, quantum perfusion blood oxygenator with integrated af and sensor vt200-c1u, quantum perfusion blood oxygenator with integrated af vt200-c2u, quantum perfusion b Qura S.r.l. K231773 11/08/2023
quantum perfusion blood oxygenator with integrated af and sensor vt200-c1u, quantum perfusion blood oxygenator with integrated af vt200-c2u, quantum perfusion blood oxygenator with integrated af and sensor vt160-c1u,quantum perfusion blood oxygenator with integrated af vt160-c2u Qura S.r.l. K212341 01/28/2022
quantum perfusion blood oxygenator ecc vt200-e1, quantum perfusion blood oxygenator ecc vt200-e2, quantum perfusion blood oxygenator ecc vt160-e1, quantum perfusion blood oxygenator ecc vt160-e2 Qura S.r.l. K203424 12/17/2021
quandrox safeline hollow fiber membrane oxygenator, model hmo 2030 JOSTRA AG K030264 02/26/2003
quadrox-ir adult and small adult MAQUET CARDIOPULMONARY AG K133265 11/12/2013
quadrox-id pediatric diffusion membrane oxygenator with bioline coating, models be-hmod 30000-usa, beq-hmod 30000-usa MAQUET CARDIOPULMONARY AG K100278 04/30/2010
quadrox-id adult diffusion membrane oxygenator with softline coating, model: be-hmod 70000-usa, beq-hmod 70000-usa, hmod MAQUET CARDIOPULMONARY AG K101153 12/08/2010
quadrox-i, quadrox-id, quadrox-ir oxygenators MAQUET CARDIOPULMONARY AG K132829 10/08/2013
quadrox-i small adult with and without intergrated arterial filter with softline coating, models hmo 50000, hmo 51000 MAQUET CARDIOPULMONARY AG K090689 10/29/2009
quadrox-i small adult microporous membrane oxygenator; w/ bioline coating and w/ integrated arterial filter w/ bioline c MAQUET CARDIOPULMONARY AG K093522 12/07/2009
quadrox-i pediatric microporous membrane oxygenator with integrated arterial filter with softline / bioline coating MAQUET CARDIOPULMONARY AG K103191 03/08/2011
quadrox-i neonatal microporous membrane oxygenator with integrated arterial filter with softline/bioline coating MAQUET CARDIOPULMONARY AG K102464 03/04/2011
quadrox-i microporporous membrane oxgenator series and qudrox-id diffusion membrane oxygenators series MAQUET CARDIOPULMONARY AG K112360 09/15/2011
quadrox-i adult/small adult oxygenators;quadrox-id adult oxygenators MAQUET CARDIOPULMONARY AG K150267 05/07/2015
quadrox-i adult with and without integrated arterial filter with softline coating, model# hmo 70000, hmo 71000 MAQUET CARDIOPULMONARY AG K082117 02/18/2009
quadrox-i adult microporous membrane oxygenator with bioline coating, model behmo70000,beq-hmo70000 MAQUET CARDIOPULMONARY AG K090511 06/12/2009
plexus 3.5(tm) pediatric hollow fiber oxygenator SHILEY, INC. K901249 06/11/1990
plexus 2(tm) infant hollow fiber oxygenator SHILEY, INC. K901250 06/11/1990
plexus 2 & 3.5 hollow fiber oxygenators SORIN BIOMEDICA, FIAT, USA, INC. K931444 05/27/1994
performa adult hollow fiber membrane oxygenator DIDECO S.R.L. K050447 03/08/2005
partner seven disp. bubble oxygenator CARDIOVASCULAR RESEARCH, INC. K800555 04/04/1980
paragon adult maxi pmp oxygenator with tubing pack Chalice Medical Ltd K201642 09/18/2020
paragon adult maxi pmp oxygenator (model: xcmop405pmp) Chalice Medical Ltd K191246 02/28/2020
oxygenators #bos-10, 105, 5s BENTLEY LABORATORIES, INC. K823456 12/30/1982
oxygenator, cobe catalog #42-220 COBE LABORATORIES, INC. K790356 03/09/1979
oxygenator, bubble type BENTLEY LABORATORIES, INC. K780078 09/14/1978
oxygenator, bubble SHILEY, INC. K772237 12/13/1977
oxygenator, blood, infant/pediatric SHILEY, INC. K781223 07/27/1978
oxygenator, blood bos-10 BENTLEY LABORATORIES, INC. K781842 11/08/1978
oxygenator model nos. bentley-10a & bentley-10b AMERICAN BENTLEY K860673 06/26/1986
oxygenator model no. bentley-10 plus AMERICAN BENTLEY K863249 10/20/1986
oxygenator model no. bentley 5 plus AMERICAN BENTLEY K872133 08/24/1987
oxygenator 10 GAMBRO, INC. K823343 12/15/1982
oxy-1 system Abiomed Inc. K200109 10/23/2020
oxy-1 system Abiomed Inc. K223161 02/23/2023
novalung surgical lung assist (sla) membrane lung NOVALUNG GMBH K072362 10/23/2007
new sterility character/sarns oxygenator products 3M HEALTH CARE, SARNS K911227 05/29/1991
monolyth mimesys hollow fiber oxygenator DIDECO K004001 10/04/2001
monolyth c 600 and 1200 hollow fiber membrane lung with integrated softshell venous reservoir , cvr 600 and 1200 softshe SORIN BIOMEDICAL, INC. K990103 11/05/1999
modified sarns oxygenator system 3M HEALTH CARE, SARNS K863515 11/18/1986
modification of maxima forte' hollow fiber oxygenator with balance biocompatible surface with plasma resistent fiber (m0 MEDTRONIC VASCULAR K984271 03/09/1999
minimax(r)/maxima(r) hollow fiber oxygenators MEDTRONIC VASCULAR K920889 09/15/1992
minimax plus hollow fiber oxygenator (with or without medtronic/carmeda bioactive surface MEDTRONIC VASCULAR K933586 02/07/1994
minimax oxygenation system MEDTRONIC VASCULAR K912655 09/13/1991
membrane oxygenator BAXTER BENTLEY LABORATORIES, INC. K882892 09/27/1988
membrane oxygenating sys adult bmos-7 & bmos-3 ped AMERICAN BENTLEY K854045 12/16/1985
medtronic minimax hollow fiber oxygenator MEDTRONIC VASCULAR K897068 08/28/1991
medos hilite pediatric oxygenator, models 2800, 2400 lt GISH BIOMEDICAL, INC. K090450 09/18/2009
medos hilite oxygenator, model 7000 & 7000 lt GISH BIOMEDICAL, INC. K082403 05/15/2009
medos hilite oxygenator MEDOS MEDIZINTECHNIK AG K140177 02/18/2014
medos hilite infant oxygenator, model 1000, 800 lt GISH BIOMEDICAL, INC. K090449 09/18/2009
medos hilite infant oxygenator MEDOS MEDIZINTECHNIK AG K140181 02/19/2014
medos hilite 7000 & 7000 lt oxygenator MEDOS MEDIZINTECHNIK AG K133261 01/09/2014
maxima* hollow fiber oxygenator w/filtered reserv. MEDTRONIC BLOOD SYSTEMS, INC. K891230 05/19/1989
maxima plus hollow fiber oxygenator MEDTRONIC VASCULAR K941473 06/21/1995
maxima plus hollow fiber oxygenator MEDTRONIC VASCULAR K925626 02/05/1993
maxima forte hollow fiber oxygenator with plasma resistant fiber MEDTRONIC VASCULAR K962641 12/16/1996
manifold AMERICAN PHARMASEAL DIV. AHSC K811004 05/08/1981
lpm/50 membrane oxygenator TRAVENOL LABORATORIES, S.A. K813255 01/18/1982
lilliput phospholypidic inert surface in oxygenation (ph.i.s.i.o.) infant/newborn hollow fiber oxygenator DIDECO S.P.A. K991737 02/17/2000
lilliput phospholypidic inert surface in oxygenation (ph.i.s.i.o.) infant hollow fibre oxygenator, model d902 DIDECO S.P.A. K001021 04/25/2000
lilliput 2 infant hollow fiber oxygenator DIDECO S.P.A. K971877 10/08/1997
lilliput 1 new born hollow fiber oxygenator DIDECO S.R.L. K953835 03/15/1996
lillipup pmp, lilliput pmp integrated SORIN GROUP ITALIA S.R.L. K151713 11/06/2015
jostra quadrox d safeline diffusion membrane oxygenator, model hmod 2030 MAQUET CARDIOPULMONARY AG K061628 08/22/2006
jostra quadrox d diffusion membrane oxygenator with bioline coating, model be-hmod 2000, beq-hmod 2030 MAQUET CARDIOPULMONARY AG K071774 01/23/2008
j & j cardiovascular maxima hollow fiber oxygenato JOHNSON & JOHNSON PROFESSIONALS, INC. K853251 10/16/1985
intersept filtered cardiotomy reservoir MEDTRONIC VASCULAR K926226 06/22/1993
interpulse membrane oxygenator EXTRACORPOREAL MEDICAL SPECIALITIES, INC. K821216 06/02/1982
interpulse membrane oxygenation system EXTRACORPOREAL MEDICAL SPECIALITIES, INC. K803003 01/22/1981
integrated unit: synthesis: adult membrane oxygenator with integrated arterial filter and hardhshell venous/cardiotomy DIDECO S.P.A. K022450 10/22/2002
integrated membrane oxygenator w/cardiotomy filter BENTLEY LABORATORIES, INC. K874841 02/02/1988
integrated membrane oxygenator w/cardiotomy filter AMERICAN BENTLEY K873923 11/06/1987
inspire 8f oxygenator with integrated arterial filter & hardshell reservoir SORIN GROUP ITALIA S.R.L. K121536 08/22/2012
inspire 8f dual hollow fiber oxygenator with integrated arterial filter and hardshell reservoir SORIN GROUP ITALIA S.R.L. K122844 10/17/2012
inspire 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir SORIN GROUP ITALIA S.R.L. K122254 08/24/2012
inspire 8 hollow fiber oxygenator with integrated hardshell reservoir, inspire 8f hollow fiber oxygenator with integrate SORIN GROUP ITALIA S.R.L. K130433 03/20/2013
inspire 8 dual hollow fiber oxygenator with with integrated hardshell venous/cardiotomy SORIN GROUP ITALIA S.R.L. K121229 07/23/2012
inspire 7fm hollow fiber oxygenator with integrated arterial filter, inspire 7f hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, inspire 7f dual hollow fiber oxygenator with integrated arterial filter and hardshell reservoir Sorin Group Italia S.R.L. K200683 06/12/2020
inspire 7 hollow fiber oxygenator with integrated hardshell/venous cardiotomy reservoir, inspire 7m hollow fiber oxygenator, inspire 7 dual hollow fiber oxygenator with integrated hardshell/venous cardiotomy reservoir SORIN GROUP ITALIA S.R.L. K190690 04/13/2019
inspire 6m hollow fiber oxygenator; inspire 6f m hollow fiber oxygenator with integrated arterial filter; inspire 8m hollow fiber oxygenator; inspire 8f m hollow fiber oxygenator with integrated arterial filter Sorin Group Italia S.r.l K180448 03/15/2018
inspire 6m hollow fiber oxygenator, inspire 7m hollow fiber oxygenator, inspire 8m hollow fiber oxygenator Sorin Group Italia S.r.l K201916 08/13/2020
inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservior SORIN GROUP ITALIA S.R.L. K120185 05/11/2012
inspire 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir SORIN GROUP ITALIA S.R.L. K113626 04/05/2012
inspire 6 hollow fiber oxygenator with integrated hardhell reservoir, inspire 6f hollow fiber oxygenator with integrated SORIN GROUP ITALIA S.R.L. K130209 02/12/2013
inspire 6 dual hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservior SORIN GROUP ITALIA S.R.L. K121909 07/26/2012
hollow fiber membrane oygenator quadrox hmo 1010 JOSTRA BENTLEY K992559 09/20/1999
hollow fiber membrane oxygenator-hf4000 CORDIS CORP. K833078 01/27/1984
hi flex d-700 modular bubble oxygena- ELECTROMEDICS, INC. K830639 05/25/1983
heparin-coated extracorporeal circuits AMERICAN BENTLEY K861641 09/29/1986
gish reliance oxygenator (model hfo) GISH BIOMEDICAL, INC. K961530 12/05/1996
extracorporeal maxima hollow fiber oxygenator EXTRACORPOREAL MEDICAL SPECIALITIES, INC. K843955 11/29/1984
extracorporeal circuit with bio-active surface MEDTRONIC BLOOD SYSTEMS, INC. K891687 05/31/1989
eos pmp, eos pmp integrated SORIN GROUP ITALIA S.R.L. K150489 06/11/2015
eos pmp Sorin Group Italia S.R.L K211495 07/12/2021
duraflo ii heparin oxygenator model univox gold BAXTER HEALTHCARE CORP. K910107 04/10/1991
dosimetric release of radiation dev AMERICAN BENTLEY K830327 03/24/1983
disposable stopcock TEXAS MEDICAL PRODUCTS, INC. K810532 04/23/1981
disp. tougy-borst type adaptor w/port STANCO MEDICAL, INC. K802328 10/10/1980
dideco d901 lilliput hollow fiber oxygenator with or without soft venous reservoir bag, with biocompatable treatment sur DIDECO K010478 09/27/2001
delta d-750 thermaflow DELTA MEDICAL INDUSTRIES K790406 11/13/1979
d902 ph.i.s.i.o oxygenator; d920 ph.i.s.i.o reservoir; dideco d736 ph.i.s.i.o filter DIDECO S.P.A. K013915 12/27/2001
d101 kids infant hollow fiber membrane oxygenator with integrated hardshell cardiotomy/venous reservoir SORIN GROUP ITALIA S.R.L. K072091 10/29/2007
d100 kids; d101 kids Sorin Group Italia S.R.L. K231652 11/16/2023
d 905 eos hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir DIDECO S.R.L. K043323 02/01/2005
d 903 avant adult hollow fiber oxygenator and d 903 avant 2 ph.i.s.i.o. adult hollow fiber oxygenator with coating DIDECO S.P.A. K033323 01/13/2004
d 903 avant 2 ph.i.s.i.o. adult hollow fiber oxygenator DIDECO S.P.A. K020351 02/26/2002
d 100 l001 ph.i.s.i.o.: newborn hollow fiber membrane oxygenator with integrated hardshell cardiotomy/venous reservoir w SORIN GROUP ITALIA S.R.L. K061031 06/02/2006
cobe(r) cml duo(r) with smart(tm) surface modified membrance oxygenator COBE CARDIOVASCULAR, INC. K974812 06/01/1998
cobe smarxt optimin surface modified hollow fiber membrane oxygenator COBE CARDIOVASCULAR, INC. K013480 11/16/2001
cobe smarxt optima xp surface modified hollow fiber membrane oxygenator COBE CARDIOVASCULAR, INC. K000255 04/25/2000
cobe oxygenator products COBE CARDIOVASCULAR, INC. K974085 01/27/1998
cobe optimin hollow fiber membrane oxygenator COBE CARDIOVASCULAR, INC. K991452 10/07/1999
cobe optima xp hollow fiber membrane oxygenator COBE CARDIOVASCULAR, INC. K963518 12/08/1997
cobe optima and cobe cml duo membrane oxygenators COBE CARDIOVASCULAR, INC. K964043 09/29/1997
cobe cms-hf hollow fiber membrane oxygenator COBE LABORATORIES, INC. K923272 05/11/1993
cobe cms-fs membrane oxygenator COBE CARDIOVASCULAR, INC. K926467 11/09/1993
cobe cml3 COBE LABORATORIES, INC. K880021 04/01/1988
cmo8 adult pmp oxygenator with tubing pack (model: cme40009) Chalice Medical Ltd K231414 11/01/2023
closed chest support circuit w/bio-active surface MEDTRONIC VASCULAR K896978 02/28/1990
closed chest support circuit MEDTRONIC BLOOD SYSTEMS, INC. K893207 12/12/1989
centrimag pre-connected pack Abbott K222297 12/01/2022
cardiovention corx system, model fg 0001 CARDIOVENTION, INC. K012325 04/09/2002
cardiovention corx ios-200 system, model ios-200 CARDIOVENTION, INC. K032068 08/22/2003
cardiopulmonary support (cps) system BARD CARDIOSURGERY DIV K892664 02/13/1990
cardiopulmonary bypass oxygenator COBE LABORATORIES, INC. K810505 04/23/1981
capix rx hollow fiber oxygenator with/without hardshell reservoir TERUMO CARDIOVASCULAR SYSTEMS CORP. K130333 03/13/2013
capiox sx25 hollow fiber oxygenator with detachable hardshell reservoir TERUMO MEDICAL CORP. K962667 10/07/1996
capiox sx18 hollow fiber oxygenator with detachable hardshell reservoir, capiox sx25 hollow fiber oxgenator with detacha TERUMO CARDIOVASCULAR SYSTEMS CORP. K130359 03/13/2013
capiox sx18 hollow fiber oxygenator with and without detachable hardshell reservoir TERUMO MEDICAL CORP. K961000 10/02/1996
capiox sx10 hollow fiber oxygenator with/without hardshell reservoir with x-coating TERUMO CARDIOVASCULAR SYSTEMS CORP. K010443 12/11/2001
capiox sx10 hollow fiber oxygenator with detachable hardshell venous reservoir TERUMO MEDICAL CORP. K960074 10/16/1996
capiox sx hollow fiber oxygenator TERUMO MEDICAL CORP. K922799 09/02/1993
capiox rx25 hollow fiber oxygenator w/wo hardshell reservoir TERUMO CORP. K040210 03/03/2004
capiox rx15 hollow, fiber oxygenator with/without hardshell reservoir TERUMO CARDIOVASCULAR SYSTEMS CORP. K051997 09/15/2005
capiox rx05 hollow fiber oxygenator/reservoir TERUMO Corporation K130493 03/13/2013
capiox rx05 hollow fiber oxygenator w/without hardshell reservoir TERUMO CORP. K022115 09/27/2002
capiox rx oxygenator with or without reservoir TERUMO CARDIOVASCULAR SYSTEMS CORP. K062381 08/24/2006
capiox rx hollow fiber oxygenator with/without hardshell reservoir Terumo Cardiovascular Systems Corporation K153213 12/03/2015
capiox iii cardiopulmonary bypass oxygenator TERUMO MEDICAL CORP. K861177 05/28/1986
capiox ii TERUMO MEDICAL CORP. K823125 11/24/1982
capiox fx15 and fx25 hollow fiber oxygenator/reservoir ASHITAKA FACTORY OF TERUMO CORP. K130520 03/13/2013
capiox fx15 and fx25 hollow fiber oxygenator and arterial filter TERUMO CORP. K071494 07/16/2007
capiox fx05 hollow fiber oxygenator with integrated arterial filter TERUMO CORP. K071572 07/23/2007
capiox fx hollow fiber oxygenator w/ reservoir TERUMO Corporation K130280 03/13/2013
capiox e hollow fiber oxygenator with integrated heat exchanger/arterial reservoir TERUMO MEDICAL CORP. K970463 05/06/1997
capiox 308 hollow fiber oxygenator w/integrated heat exchange TERUMO MEDICAL CORP. K961734 07/07/1997
built-in temperature monitoring BENTLEY LABORATORIES, INC. K801240 06/04/1980
bubble-type oxygenator COBE LABORATORIES, INC. K772284 02/02/1978
bos-cm40,50 holder & reservoir bag AMERICAN BENTLEY K833670 01/03/1984
bos-2s, spiraflo bubble infant oxygen. BENTLEY LABORATORIES, INC. K823273 01/05/1983
blood oxygenators #bos-105s bos-5s w/ BENTLEY LABORATORIES, INC. K822803 11/01/1982
blood oxygenator model no. max-5 AMERICAN BENTLEY K850630 03/27/1985
blood oxygenator heat exhanger coating AMERICAN BENTLEY K833518 12/29/1983
blood oxygenator 5070 SHILEY, INC. K831894 10/20/1983
blood oxygenator 50 70/s SHILEY, INC. K831895 10/19/1983
biocor 200 high performanceoxygenator MINNTECH CORP. K964967 03/06/1997
bard(r) wm harvey(r) blood oxygenator/model h-1600 C.R. BARD, INC. K864235 01/02/1987
bard wm harvey hf-5700 memb oxygen w/hardshell res BARD CARDIOSURGERY DIV K892641 11/01/1989
bard william harvey hf-6000 membrane oxygenator C.R. BARD, INC. K954850 10/30/1996
apex ph.i.s.i.o. adult hollow fiber membrane oxygenator DIDECO S.P.A. K020997 04/04/2002
apex hp m ph.i.s.i.o. adult hollow fiber membrane oxygenator SORIN GROUP ITALIA S.R.L. K083021 10/29/2008
apex hp m adult hollow fiber membrane oxygenator SORIN GROUP ITALIA S.R.L. K092895 10/19/2009
apex adult hollowe fiber oxygenator DIDECO S.P.A. K014080 01/08/2002
amg pmp pediatric Eurosets S.r.l. K202206 04/01/2021
amg pmp infant Eurosets S.r.l. K202510 12/10/2021
american bentley oxygenator max-2 AMERICAN BENTLEY K851035 05/16/1985
amer. bentley oxygenator max-10 w/smooth heat exch AMERICAN BENTLEY K844901 03/07/1985
affinity pixie™ oxygenator with balance™ biosurface (model bbp211), affinity pixie™ oxygenator and cardiotomy/venous reservoir with balance™ biosurface (model bbp241), affinity pixie™ oxygenator with cortiva™ bioactive surface (model cbp211), affinity pixie™ oxygenator and cardiotomy/venous reservo Medtronic Inc K183511 03/18/2019
affinity pixie oxygenator with balance biosurface, affinity pixie oxygenator with cardiotomy/venous reservoir and balance biosurface, affinity pixie oxygenator with cortiva bioactive surface, affinity fusion oxygenator with cardiotomy/venous reservoir and cortiva bioactive surface Medtronic, Inc. K172984 11/20/2017
affinity pixie oxygenation system with carmeda bioactive surface or balance biosurface MEDTRONIC INC. K100645 09/14/2012
affinity nttm oxygenator (model 511), affinity® nt hollow fiber oxygenator with plasma resistant fiber (prf) with trilliumtm biosurface (model 511t), affinity® nt integrated cvr/membrane oxygenator with plasma resistant fiber (model 541), affinity® nt integrated cvr/membrane oxygenator with plasma Medtronic, Inc. K191029 05/17/2019
affinity nt oxygenator, affinity nt oxygenator with trillium biosurface, affinity nt oxygenator with cortiva bioactive surface, affinity fusion oxygenator with cortiva bioactive surface, affinity fusion oxygenator with balance biosurface Medtronic Inc K183490 04/12/2019
affinity nt oxygenator, affinity nt oxygenator with trillium biosurface, affinity nt oxygenator with carmeda biosurface Medtronic, Inc. K143073 03/25/2015
affinity nt oxygenator, affinity nt oxygenator with trillium biosurface MEDTRONIC, INC. K162896 12/06/2016
affinity nt oxygenator with cortiva bioactive surface MEDTRONIC, INC. K162016 09/21/2016
affinity nt oxygenator with balance biosurface, affinity nt oxygenator with balance biosurface and uncoated cardiotomy/venous reservoir Medtronic, Inc. K191444 09/27/2019
affinity nt hollow fiber oxygenator with plasma resistant fiber with carmeda bioactive surface, model cb511 MEDTRONIC VASCULAR K000430 02/25/2000
affinity nt hollow fiber oxygenator with plasma resistant fiber with balance biocompatible surface (model 511b) MEDTRONIC VASCULAR K992910 09/15/1999
affinity hollow fiber oxygenator with trillium biopassive surface AVECOR CARDIOVASCULAR, INC. K973760 02/18/1998
affinity hollow fiber oxygenator AVECOR CARDIOVASCULAR, INC. K932252 11/19/1993
affinity fusion™ oxygenator system Medtronic Inc. K230640 04/06/2023
affinity fusion oxygenator with integrated arterial filter and carmeda bioactive surface MEDTRONIC INC. K123314 01/22/2013
affinity fusion oxygenator with integrated arterial filter and balance biosurface, affinity fusion oxygenator with integrated arterial filter and carmeda bioactive surface Medtronic, Inc K142784 10/24/2014
affinity fusion oxygenator with integrated arterial filter and balance biosurface model bb811 MEDTRONIC INC. K122827 12/14/2012
affinity fusion oxygenator with balance biosurface, affinity fusion oxygenator with cardiotomy/venous reservoir and balance biosurface, affinity fusion oxygenator with cortiva biosurface, affinity fusion oxygenator with cortiva bioactive surface & cardiotomy/venous reservoir Medtronic, Inc. K172626 10/25/2017
affinity fusion oxygenator system, affinity pixie oxygenation system Medtronic K203111 09/16/2021
affinity cp centrifugal pump, resting heart sys.,myotherm cardioplegia deliv.,affinity hollow fiber oxygenator,aaf MEDTRONIC INC. K111972 07/27/2011
advanced membrane gas exchange (amg), amg oxygenaling module, amg venous cardiotomy resevoir 4500 model eu5011, eu5012 EUROSETS S.R.L. K102109 02/15/2011
advanced membrance gas exchange pmp sterile (a.m.g pmp sterile) EUROSETS S.R.L. K141492 02/06/2015
(pbs) portable bypass system, model 1000 BIO MEDICUS, INC. K901253 09/05/1990
 
 
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