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Terumo Cardiovascular Systems Corp

209 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular recall (Z-2786-2015)Terumo Cardiovascular Systems Corp2015-09-18
Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovasc recall (Z-2787-2015)Terumo Cardiovascular Systems Corp2015-09-18
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-0 recall (Z-2788-2015)Terumo Cardiovascular Systems Corp2015-09-18
Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Ca recall (Z-2789-2015)Terumo Cardiovascular Systems Corp2015-09-18
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Ca recall (Z-2790-2015)Terumo Cardiovascular Systems Corp2015-09-18
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo recall (Z-2791-2015)Terumo Cardiovascular Systems Corp2015-09-18
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo recall (Z-2792-2015)Terumo Cardiovascular Systems Corp2015-09-18
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the ext recall (Z-1828-2015)Terumo Cardiovascular Systems Corp2015-06-23
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbe recall (Z-0156-2015)Terumo Cardiovascular Systems Corp2014-10-31
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: recall (Z-0157-2015)Terumo Cardiovascular Systems Corp2014-10-31
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Deliv recall (Z-0158-2015)Terumo Cardiovascular Systems Corp2014-10-31
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-dig recall (Z-0159-2015)Terumo Cardiovascular Systems Corp2014-10-31
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Pr recall (Z-0160-2015)Terumo Cardiovascular Systems Corp2014-10-31
Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a rep recall (Z-0161-2015)Terumo Cardiovascular Systems Corp2014-10-31
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Numb recall (Z-1465-2014)Terumo Cardiovascular Systems Corp2014-04-16
Terumo Custom Cardiovascular Procedure Kit (manufactured to the design and specifications recall (Z-1523-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications o recall (Z-1524-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications o recall (Z-1525-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications o recall (Z-1526-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications o recall (Z-1527-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications o recall (Z-1528-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications o recall (Z-1529-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACK Product Code: 71062-01 Manufactu recall (Z-1530-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit-: CUSTOM X-COATED LOW PRIME Product Code:72015- recall (Z-1531-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 Product Code:720 recall (Z-1532-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 x1/2 pack Produc recall (Z-1533-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RW30 Product Code:73 recall (Z-1534-2012)Terumo Cardiovascular Systems Corp2012-05-11
Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40 Product Code:73 recall (Z-1535-2012)Terumo Cardiovascular Systems Corp2012-05-11
Cardiovascular Custom Procedure Kits, REV OA PERFUSION W/4:1 CARDIOPLEGIA Item Number 7299 recall (Z-3222-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 X-COATED 8:1 FX PACK Ite recall (Z-3223-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, Rev OA FX 8:1 PACK Item Number :73315 Terumo Cardiov recall (Z-3224-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number: 73329 Teru recall (Z-3225-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item N recall (Z-3226-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV..1 X-Coated Stand Alone Adult Pack Item Number: recall (Z-3227-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.2, REV. 3 PUMP & TABLE PACK 1/4 Terumo Cardiovas recall (Z-3228-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.3, REV. 5 X-COATED 8:1 CARDIOPLEGIA Item Number: recall (Z-3229-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.OB PERFUSION W/8:1 CARDIOPLEGIA Item Number: 716 recall (Z-3230-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.4, REV. 5 X-COATED NEONATAL PACK 3/16" Item Numb recall (Z-3231-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.0, REV 1, REV 1A, REV. 2 XCoated 8:1 FX PACK Ite recall (Z-3232-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.0 FX 8:1 PACK Item Number: 73329 Terumo Cardiova recall (Z-3233-2011)Terumo Cardiovascular Systems Corp2011-09-16
Adjustable Valve Item Number: 73631 Terumo Cardiovascular Systems, Ashland, MA 01721 The C recall (Z-3234-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 2 X-COATED 3/8 X 3/8 A-V LOOP Item Number: 7394 recall (Z-3235-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 1 X-COATED 3/8 X 1/2 A-V LOOP Item Number: 7395 recall (Z-3236-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 5 X-COATED FPS ADULT PACK Item Number: 73325 Te recall (Z-3237-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 5 STANDARD PACK Item Number: 71701 Terumo Cardi recall (Z-3238-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV :10. REV 13, REV17, REV 18 FX X-Coated Perfusion recall (Z-3239-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV :2. REV 2A, REV: 17, REV 18 X-COATED FX PACK Ite recall (Z-3240-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV :3. REV: 4, REV: 5, REV: 6, REV:7 X-Coated 8000 recall (Z-3241-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV : 2, REV: 4 FX, CP50,CENT Pack Item Number: 7338 recall (Z-3242-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV : 3 General Low Prime Item Number: 73563 Terumo recall (Z-3243-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 2, REV:2A, REV: 5, REV: 7 X-Coated FX PERFUSION recall (Z-3244-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 0, REV: 1 REV: 4, REV: 6A, REV: 6B. REV: 6C COA recall (Z-3245-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 1 REV: 1A COATED FX PK Item Number: 72985-02 Te recall (Z-3246-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number: 73191 T recall (Z-3247-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 1A, REV :1 X-COATED FX PK Item Number: 73191-01 recall (Z-3248-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 8 Comprensive X-COATED 8000 FX PK Item Number: recall (Z-3249-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 4 FX, CP50 CENT. PK Item Number: 73386 Terumo C recall (Z-3250-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 3, REV: 3A, REV:4 FX, CP50 CENT. PK Item Number recall (Z-3251-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 0, REV: 2, REV:6 X-Coated FX Perfusion Pack Ite recall (Z-3252-2011)Terumo Cardiovascular Systems Corp2011-09-16
Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937 recall (Z-2149-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA P/N 6 recall (Z-2150-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP & TABL recall (Z-2151-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N 70608-01 recall (Z-2152-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE PACK P/N 71544-01 recall (Z-2153-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01 recall (Z-2154-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom PERFUSION TUBING PACK P/N 71733 recall (Z-2155-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG FRAMEPACK P/N 71766PP recall (Z-2156-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK P/N 71934 recall (Z-2157-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED PUMP AND TABLE PACK W/8:1 CARDIOPLEGIA recall (Z-2158-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N 72790 recall (Z-2159-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N 72846 recall (Z-2160-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02 recall (Z-2161-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG PACK P/N: 70608-01 recall (Z-2162-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 7 recall (Z-2163-2010)Terumo Cardiovascular Systems Corp2010-08-02
Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-co recall (Z-1310-2008)Terumo Cardiovascular Systems Corp2008-03-28
Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Tab recall (Z-1311-2008)Terumo Cardiovascular Systems Corp2008-03-28
Cardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump & Table Pac recall (Z-1312-2008)Terumo Cardiovascular Systems Corp2008-03-28
Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump & Table Pac recall (Z-1313-2008)Terumo Cardiovascular Systems Corp2008-03-28
Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo perf recall (Z-0530-2008)Terumo Cardiovascular Systems Corp2008-01-24
Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo pe recall (Z-0531-2008)Terumo Cardiovascular Systems Corp2008-01-24
Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo per recall (Z-0532-2008)Terumo Cardiovascular Systems Corp2008-01-24
Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Teru recall (Z-0321-2008)Terumo Cardiovascular Systems Corp2007-12-01
Terumo Advanced Perfusion System, 1 Roller Pump, 6 inch diameter; Catalog No. 801041, Teru recall (Z-0322-2008)Terumo Cardiovascular Systems Corp2007-12-01
Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Num recall (Z-0323-2008)Terumo Cardiovascular Systems Corp2007-12-01
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented conne recall (Z-0874-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented co recall (Z-0875-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented conne recall (Z-0876-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented co recall (Z-0877-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented conn recall (Z-0878-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented recall (Z-0879-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented con recall (Z-0880-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented recall (Z-0881-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented conn recall (Z-0882-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented recall (Z-0883-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented con recall (Z-0884-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented recall (Z-0885-2007)Terumo Cardiovascular Systems Corp2007-07-10
Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402. recall (Z-1002-2007)Terumo Cardiovascular Systems Corp2007-07-07
Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407. recall (Z-1003-2007)Terumo Cardiovascular Systems Corp2007-07-07
Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395. recall (Z-1004-2007)Terumo Cardiovascular Systems Corp2007-07-07
Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distr recall (Z-1005-2007)Terumo Cardiovascular Systems Corp2007-07-07
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Every clearance here is in the API, with alerts when new ones post.