ClearanceBrief
Panels › Cardiovascular › Product code DTZ · Class 2

Oxygenator, Cardiopulmonary Bypass

Regulation 870.4350

5510(k)s in 12 months (255 all time)
1recalls in 12 months (107 all time)
98recalls that name a 510(k)
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Top companies in DTZ

Company510(k)sRecalls
Terumo Cardiovascular Systems Corp.1221
Maquet Medical Systems USA022
Sorin Group Italia S.R.L.220
Medtronic162
Cobe Cardiovascular, Inc.88
Medtronic Perfusion Systems114
American Bentley130
Maquet Cardiopulmonary, AG130
Dideco120
Medtronic Vascular120
Decided510(k)Device and applicantCode
Feb 18, 2014K140177MEDOS HILITE OXYGENATOR
Medos Medizintechnik AG
DTZ
Jan 9, 2014K133261MEDOS HILITE 7000 & 7000 LT OXYGENATOR
Medos Medizintechnik AG
DTZ
Oct 8, 2013K132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
Maquet Cardiopulmonary, AG
DTZ
Mar 20, 2013K130433INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE
Sorin Group Italia S.R.L.
DTZ
Mar 13, 2013K130520CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
Ashitaka Factory of Terumo Corp., JP
DTZ
Mar 13, 2013K130493CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
Terumo Corporation
DTZ
Mar 13, 2013K130359CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
Terumo Cardiovascular Systems Corp.
DTZ
Mar 13, 2013K130333CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
Terumo Cardiovascular Systems Corp.
DTZ
Mar 13, 2013K130280CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
Terumo Corporation
DTZ
Feb 12, 2013K130209INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED
Sorin Group Italia S.R.L.
DTZ
Jan 22, 2013K123314AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE
Medtronic, Inc.
DTZ
Dec 14, 2012K122827AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811
Medtronic, Inc.
DTZ
Oct 17, 2012K122844INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR
Sorin Group Italia S.R.L.
DTZ
Sep 14, 2012K100645AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
Medtronic, Inc.
DTZ
Aug 24, 2012K122254INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
Sorin Group Italia S.R.L.
DTZ
Aug 22, 2012K121536INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
Sorin Group Italia S.R.L.
DTZ
Jul 26, 2012K121909INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
Sorin Group Italia S.R.L.
DTZ
Jul 23, 2012K121229INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
Sorin Group Italia S.R.L.
DTZ
May 11, 2012K120185INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
Sorin Group Italia S.R.L.
DTZ
Apr 5, 2012K113626INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
Sorin Group Italia S.R.L.
DTZ
Sep 15, 2011K112360QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES
Maquet Cardiopulmonary, AG, DE
DTZ
Mar 8, 2011K103191QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
Maquet Cardiopulmonary, AG, DE
DTZ
Mar 4, 2011K102464QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
Maquet Cardiopulmonary, AG, DE
DTZ
Feb 15, 2011K102109ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012
Eurosets S.R.L, IT
DTZ
Dec 8, 2010K101153QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
Maquet Cardiopulmonary, AG, DE
DTZ
Apr 30, 2010K100278QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
Maquet Cardiopulmonary, AG, DE
DTZ
Dec 7, 2009K093522QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C
Maquet Cardiopulmonary, AG, DE
DTZ
Oct 29, 2009K090689QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
Maquet Cardiopulmonary, AG, DE
DTZ
Oct 19, 2009K092895APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
Sorin Group Italia S.R.L.
DTZ
Sep 18, 2009K090450MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
Gish Biomedical, Inc.
DTZ
Sep 18, 2009K090449MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
Gish Biomedical, Inc.
DTZ
Jun 12, 2009K090511QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
Maquet Cardiopulmonary, AG, DE
DTZ
May 15, 2009K082403MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
Gish Biomedical, Inc.
DTZ
Feb 18, 2009K082117QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
Maquet Cardiopulmonary, AG, DE
DTZ
Feb 2, 2009K080708VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
Gish Biomedical, Inc.
DTZ
Oct 29, 2008K083021APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
Sorin Group Italia S.R.L.
DTZ
Feb 29, 2008K073380SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI
Sorin Group Italia S.R.L.
DTZ
Jan 23, 2008K071774JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
Maquet Cardiopulmonary, AG, DE
DTZ
Oct 29, 2007K072091D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR
Sorin Group Italia S.R.L.
DTZ
Oct 23, 2007K072362NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG
Novalung GmbH
DTZ
Jul 23, 2007K071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
Terumo Corp.
DTZ
Jul 16, 2007K071494CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
Terumo Corp.
DTZ
Aug 24, 2006K062381CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR
Terumo Cardiovascular Systems Corp.
DTZ
Aug 22, 2006K061628JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
Maquet Cardiopulmonary, AG
DTZ
Jun 2, 2006K061031D 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.
DTZ
Sep 15, 2005K051997CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
Terumo Cardiovascular Systems Corp.
DTZ
Mar 8, 2005K050447PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
Dideco S.R.L.
DTZ
Feb 1, 2005K043323D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
Dideco S.R.L.
DTZ
Mar 3, 2004K040210CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
Terumo Corp.
DTZ
Mar 3, 2004K031903RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568
Guidant Corporation
DTZ

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