BEUDAMED
    26 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Terminated × Clear all

    Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 4, 2012

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·November 24, 2021

    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·November 24, 2021

    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·November 24, 2021

    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·November 24, 2021

    Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer

    FDA Enforcement
    Class I ·Terminated·ARROW INTERNATIONAL Inc.·December 21, 2022

    Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer

    FDA Enforcement
    Class I ·Terminated·ARROW INTERNATIONAL Inc.·December 21, 2022

    FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    FDA Enforcement
    Class I ·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016

    Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    FDA Enforcement
    Class I ·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016

    FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    FDA Enforcement
    Class I ·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016