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Terumo Cardiovascular Systems Corporation

327 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented recall (Z-0637-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented conn recall (Z-0638-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented recall (Z-0639-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented con recall (Z-0640-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented recall (Z-0641-2009)Terumo Cardiovascular Systems Corporation2009-02-06
Terumo Advanced Perfusion System 1 Air Bubble Detection Module, Terumo Cardiovascular Syst recall (Z-0670-2009)Terumo Cardiovascular Systems Corporation2009-01-29
Terumo Advanced Perfusion System 1 Pressure Monitoring Unit, Terumo Cardiovascular Systems recall (Z-0671-2009)Terumo Cardiovascular Systems Corporation2009-01-29
Terumo Advanced Perfusion System 1 Temperature Monitoring Systems, Terumo Cardiovascular S recall (Z-0672-2009)Terumo Cardiovascular Systems Corporation2009-01-29
Terumo Advanced Perfusion System 1 Pressure Venous Occluder, Terumo Cardiovascular Systems recall (Z-0673-2009)Terumo Cardiovascular Systems Corporation2009-01-29
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump, Terumo Cardiovascular Sys recall (Z-0674-2009)Terumo Cardiovascular Systems Corporation2009-01-29
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A powe recall (Z-0445-2009)Terumo Cardiovascular Systems Corporation2008-12-29
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power recall (Z-0446-2009)Terumo Cardiovascular Systems Corporation2008-12-29
Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump; Model 801040). Extracorpo recall (Z-0354-2009)Terumo Cardiovascular Systems Corporation2008-12-11
Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump; Model 801041). Extracorpo recall (Z-0355-2009)Terumo Cardiovascular Systems Corporation2008-12-11
Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). Extr recall (Z-0356-2009)Terumo Cardiovascular Systems Corporation2008-12-11
Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump, Gray; Model 816571). Extr recall (Z-0357-2009)Terumo Cardiovascular Systems Corporation2008-12-11
Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusi recall (Z-0311-2009)Terumo Cardiovascular Systems Corporation2008-12-10
Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., recall (Z-0358-2009)Terumo Cardiovascular Systems Corporation2008-12-02
Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Co recall (Z-0359-2009)Terumo Cardiovascular Systems Corporation2008-12-02
Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. The Terumo( recall (Z-0309-2009)Terumo Cardiovascular Systems Corporation2008-11-25
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. The Terumo( recall (Z-0310-2009)Terumo Cardiovascular Systems Corporation2008-11-25
Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level sensor transducer for us recall (Z-0295-2009)Terumo Cardiovascular Systems Corporation2008-11-07
Terumo Sarns Level Sensor II (red) (Part # 195274) alarm level sensor transducer for use w recall (Z-0296-2009)Terumo Cardiovascular Systems Corporation2008-11-07
Terumo Advanced Perfusion System 1 Base, 100/120V; Model 801763. For use for up to 6 hours recall (Z-0203-2009)Terumo Cardiovascular Systems Corporation2008-11-06
Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This product is not distribut recall (Z-0204-2009)Terumo Cardiovascular Systems Corporation2008-11-06
Terumo Advanced Perfusion System 1 base, 110/120V; Model 801763. For use for up to 6 hours recall (Z-0205-2009)Terumo Cardiovascular Systems Corporation2008-10-31
Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in th recall (Z-0206-2009)Terumo Cardiovascular Systems Corporation2008-10-31
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Every clearance here is in the API, with alerts when new ones post.