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Terumo Cardiovascular Systems Corporation

327 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 8.0mm (24Fr) OD with 3/8" con recall (Z-1302-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) O recall (Z-1303-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced 7.0mm (21 Fr recall (Z-1304-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer po recall (Z-1305-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 7.0mm (21 Fr) OD with 3/8" co recall (Z-1306-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 7.0mm (21 Fr) recall (Z-1307-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 6.0mm (18 recall (Z-1308-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer recall (Z-1309-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer recall (Z-1310-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer po recall (Z-1311-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Glendale Memorial XCoated Pack Product Usage: The Sarns-Aortic Cannula is indicated for us recall (Z-1312-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Glendale Memorial XCoated Pack Product Usage: The Sarns-Aortic Cannula is indicated for us recall (Z-1313-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Glendale Memorial Fx Pack Product Usage: The Sarns-Aortic Cannula is indicated for use In recall (Z-1314-2012)Terumo Cardiovascular Systems Corporation2012-03-23
Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for recall (Z-0978-2012)Terumo Cardiovascular Systems Corporation2012-02-07
Roller Pump, 4 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use f recall (Z-0839-2012)Terumo Cardiovascular Systems Corporation2012-01-24
Roller Pump, 6 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use f recall (Z-0840-2012)Terumo Cardiovascular Systems Corporation2012-01-24
CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Satu recall (Z-0604-2012)Terumo Cardiovascular Systems Corporation2012-01-11
CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitorin recall (Z-0672-2012)Terumo Cardiovascular Systems Corporation2012-01-11
CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitorin recall (Z-0673-2012)Terumo Cardiovascular Systems Corporation2012-01-11
CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitorin recall (Z-0674-2012)Terumo Cardiovascular Systems Corporation2012-01-11
CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitorin recall (Z-0675-2012)Terumo Cardiovascular Systems Corporation2012-01-11
The Terumo Advanced Perfusion System 1, Catalog Number 801763, System 1 Base, 110 V Produc recall (Z-0298-2012)Terumo Cardiovascular Systems Corporation2011-11-29
The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V Product recall (Z-0299-2012)Terumo Cardiovascular Systems Corporation2011-11-29
Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 (gray) Product Usag recall (Z-0300-2012)Terumo Cardiovascular Systems Corporation2011-11-29
Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 Product Usage: The recall (Z-0301-2012)Terumo Cardiovascular Systems Corporation2011-11-29
Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1 Product Usage: The recall (Z-0302-2012)Terumo Cardiovascular Systems Corporation2011-11-29
Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Pe recall (Z-0303-2012)Terumo Cardiovascular Systems Corporation2011-11-29
CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalo recall (Z-0142-2012)Terumo Cardiovascular Systems Corporation2011-10-31
Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a recall (Z-0053-2012)Terumo Cardiovascular Systems Corporation2011-10-17
SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE recall (Z-0054-2012)Terumo Cardiovascular Systems Corporation2011-10-17
Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 42 recall (Z-3214-2011)Terumo Cardiovascular Systems Corporation2011-09-15
Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to atta recall (Z-3176-2011)Terumo Cardiovascular Systems Corporation2011-09-09
VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiova recall (Z-2854-2011)Terumo Cardiovascular Systems Corporation2011-07-21
System 1 Base 110V, Catalog 801763, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI Th recall (Z-2735-2011)Terumo Cardiovascular Systems Corporation2011-07-06
System 1 Base 220V, Catalog 801764, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI Th recall (Z-2736-2011)Terumo Cardiovascular Systems Corporation2011-07-06
Large Roller Pump 6" Diameter, Catalog 816571, Terumo Cardiovascular Systems, Corp., Ann A recall (Z-2737-2011)Terumo Cardiovascular Systems Corporation2011-07-06
Large Roller Pump 6" Diameter, Catalog 801041, Terumo Cardiovascular Systems, Corp., Ann A recall (Z-2738-2011)Terumo Cardiovascular Systems Corporation2011-07-06
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and recall (Z-2678-2011)Terumo Cardiovascular Systems Corporation2011-06-28
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blo recall (Z-2679-2011)Terumo Cardiovascular Systems Corporation2011-06-28
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial and recall (Z-2680-2011)Terumo Cardiovascular Systems Corporation2011-06-28
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blo recall (Z-2681-2011)Terumo Cardiovascular Systems Corporation2011-06-28
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with venous blood recall (Z-2682-2011)Terumo Cardiovascular Systems Corporation2011-06-28
Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring system, cat recall (Z-2683-2011)Terumo Cardiovascular Systems Corporation2011-06-28
Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system, cat recall (Z-2684-2011)Terumo Cardiovascular Systems Corporation2011-06-28
CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM recall (Z-2610-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The recall (Z-2613-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit Part number 70667-01 Eisenhower Army Med Center Heart Lung Pa recall (Z-2614-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit Part number 70667 Eisenhower Army Med Center Heart Lung Pack, recall (Z-2615-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit Part number 70367-07 Mission St. Joe's - Asheville X-Coated L recall (Z-2616-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit Part number 72427, Oklahoma Heart Hospital X-Coated System 1 recall (Z-2617-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit, Part number 65418-01, Terumo Latin America Seminsa Pediatric recall (Z-2618-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit, Part number 65672-01, Terumo Latin America Seminsa lactante, recall (Z-2619-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit, Part number 65870, Terumo Latin America Pediatric Pack, Ster recall (Z-2620-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit, Part number 65871, Terumo Latin America Lactante Pack, Steri recall (Z-2621-2011)Terumo Cardiovascular Systems Corporation2011-06-22
804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary bypass vas recall (Z-2554-2011)Terumo Cardiovascular Systems Corporation2011-06-14
804117, Terumo Coronary Ostia cannula, 12 Fr, 10 (25 cm) long A cardiopulmonary bypass vas recall (Z-2555-2011)Terumo Cardiovascular Systems Corporation2011-06-14
804159, Terumo Coronary Ostia cannula, 14 Fr, 10 (25 cm) long A cardiopulmonary bypass vas recall (Z-2556-2011)Terumo Cardiovascular Systems Corporation2011-06-14
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules recall (Z-2185-2011)Terumo Cardiovascular Systems Corporation2011-05-12
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematoc recall (Z-2186-2011)Terumo Cardiovascular Systems Corporation2011-05-12
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules recall (Z-2187-2011)Terumo Cardiovascular Systems Corporation2011-05-12
CDI Blood Parameter Monitoring System 500 with Arterial Blood parameter module Catalog num recall (Z-2188-2011)Terumo Cardiovascular Systems Corporation2011-05-12
CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog numbe recall (Z-2189-2011)Terumo Cardiovascular Systems Corporation2011-05-12
Sarns Flexible Weighted Sucker, Sterile, catalog 804113, Terumo Cardiovascular Systems, An recall (Z-2001-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile recall (Z-2002-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Sarns Flexible Weighted Sucker in WI CARDIOVASCULAR PUMP & TABLE PACK (custom pack), catal recall (Z-2003-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-02 recall (Z-2004-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-03 recall (Z-2005-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-04 recall (Z-2006-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Sarns Flexible Weighted Sucker in PUMP & TABLE PACK with PALL (custom pack), catalog numbe recall (Z-2007-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Sarns Flexible Weighted Sucker in PUMP & TABLE PACK with PALL (custom pack), catalog numbe recall (Z-2008-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Sarns Flexible Weighted Sucker in X-COATED CUSTOM TUBING PACK, catalog number 70932-01, St recall (Z-2009-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number 73013-01, recall (Z-2010-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number 73013-02, recall (Z-2011-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Sarns Flexible Weighted Sucker in X-COATED PUMP & TABLE PACK, catalog number 73067-01, Ste recall (Z-2012-2011)Terumo Cardiovascular Systems Corporation2011-04-15
Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitorin recall (Z-1943-2011)Terumo Cardiovascular Systems Corporation2011-04-11
Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitori recall (Z-1944-2011)Terumo Cardiovascular Systems Corporation2011-04-11
Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo Cardiovascu recall (Z-1566-2011)Terumo Cardiovascular Systems Corporation2011-03-07
Terumo Advanced Perfusion System 1, 220/240V System 1 Base, REF 801764, Terumo Cardiovascu recall (Z-1567-2011)Terumo Cardiovascular Systems Corporation2011-03-07
Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Ter recall (Z-1230-2011)Terumo Cardiovascular Systems Corporation2011-02-14
Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terum recall (Z-0968-2011)Terumo Cardiovascular Systems Corporation2011-01-26
Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI recall (Z-0882-2011)Terumo Cardiovascular Systems Corporation2011-01-07
Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI. The occ recall (Z-0883-2011)Terumo Cardiovascular Systems Corporation2011-01-07
Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No recall (Z-0562-2011)Terumo Cardiovascular Systems Corporation2010-12-08
Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No recall (Z-0563-2011)Terumo Cardiovascular Systems Corporation2010-12-08
Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Car recall (Z-0024-2011)Terumo Cardiovascular Systems Corporation2010-10-08
Terumo Advanced Perfusion System 1, Catalog number 801763, 100/120V System 1 base, Terumo recall (Z-2480-2010)Terumo Cardiovascular Systems Corporation2010-09-23
Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo recall (Z-2481-2010)Terumo Cardiovascular Systems Corporation2010-09-23
Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, recall (Z-0544-2010)Terumo Cardiovascular Systems Corporation2009-12-17
Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf boxe recall (Z-0545-2010)Terumo Cardiovascular Systems Corporation2009-12-17
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo recall (Z-2046-2009)Terumo Cardiovascular Systems Corporation2009-08-04
Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, recall (Z-1224-2009)Terumo Cardiovascular Systems Corporation2009-05-29
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A powe recall (Z-0909-2009)Terumo Cardiovascular Systems Corporation2009-02-24
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power recall (Z-0910-2009)Terumo Cardiovascular Systems Corporation2009-02-24
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented conne recall (Z-0630-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented co recall (Z-0631-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented conne recall (Z-0632-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented co recall (Z-0633-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented conn recall (Z-0634-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented recall (Z-0635-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented con recall (Z-0636-2009)Terumo Cardiovascular Systems Corporation2009-02-06
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Every clearance here is in the API, with alerts when new ones post.