BEUDAMED
    1,484 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow Percutaneous Thrombolytic Device (PTD) for fistula and dialysis grafts

    FDA Recall
    Terminated ·Arrow International Inc·Product code MCW·February 11, 2009

    Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts

    FDA Recall
    Terminated ·Arrow International Inc·Product code DXE·February 11, 2009

    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 Recall
    Terminated ·Arrow International Inc·Product code DXE·September 20, 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 Recall
    Terminated ·Arrow International Inc·Product code DXE·September 20, 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 Recall
    Terminated ·Arrow International Inc·Product code DXE·September 20, 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 Recall
    Terminated ·Arrow International Inc·Product code DXE·September 20, 2021

    ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·May 10, 2023

    CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·May 10, 2023

    CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·May 10, 2023

    OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300 M. 10.0ml.) PN: 50003300; Store at d - 15C. Product Usage: General Purpose Reagent for laboratory use.

    FDA Recall
    Terminated ·Celera Corporation·Product code LDT·July 12, 2013

    There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.

    FDA Recall
    Terminated ·Nucletron BV Waardgelder 1 POBox 930 Veenendaal Netherlands·Product code JAQ·November 18, 2019

    Ellex Solo LT5106-S ophthalmic laser (not sold in USA)

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

    Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009