143 results
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Sources: EU EUDAMED, US FDA
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CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
FDA Enforcement
Class II
·Completed·CardioTek BV·July 12, 2017
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
FDA Enforcement
Class II
·Terminated·Nucletron BV·November 1, 2017
VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
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 Enforcement
Class II
·Terminated·Nucletron BV·January 8, 2020
VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
(1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
(1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
CardioTek EP-TRACER Software V2.x.
FDA Enforcement
Class II
·Completed·CardioTek BV·June 29, 2022