BEUDAMED
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    Bluegrass Vascular Technologies, Inc.

    Manufacturer
    🇺🇸 United States

    HEMOLUNG RAS

    FDA Adverse Event
    Injury ·ALUNG TECHNOLOGIES, INC·Product code DQR·January 16, 2023

    HEMOLUNG RAS

    FDA Adverse Event
    Death ·ALUNG TECHNOLOGIES, INC.·Product code QLN·January 18, 2023

    Surfacer Inside-Out Access Catheter System

    FDA UDI
    BLUEGRASS VASCULAR TECHNOLOGIES, INC.·00860003451601·

    REVANESSE LIPS+ 1.2 ML

    FDA Adverse Event
    Injury ·PROLLENIUM MEDICAL TECHNOLOGIES INC.·Product code LMH·May 15, 2023

    HEMOLUNG RAS

    FDA Adverse Event
    Injury ·ALUNG TECHNOLOGIES, INC.·Product code QOH·January 18, 2023

    REVANESSE VERSA+ 1.2 ML

    FDA Adverse Event
    Injury ·PROLLENIUM MEDICAL TECHNOLOGIES, AURORA, ON·Product code LMH·November 19, 2024

    VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

    FDA Recall
    Terminated ·Vascular Technology, Inc.·Product code DPW·June 19, 2018

    HEMOLUNG RAS

    FDA Adverse Event
    Malfunction ·ALUNG TECHNOLOGIES, INC.·Product code DQR·January 18, 2023

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code PRL·March 25, 2024

    VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Recall
    Terminated ·Vascular Technology, Inc.·Product code DPW·May 28, 2014

    07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Recall
    Terminated ·Vascular Technology, Inc.·Product code DPW·May 28, 2014

    07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Recall
    Terminated ·Vascular Technology, Inc.·Product code DPW·May 28, 2014

    07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Recall
    Terminated ·Vascular Technology, Inc.·Product code DPW·May 28, 2014

    SOUNDSTAR ECO 8F ULTRASOUND CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code OBJ·September 15, 2022

    SOUNDSTAR ECO 8F ULTRASOUND CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code OBJ·September 20, 2022

    07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Enforcement
    Class II ·Terminated·Vascular Technology, Inc.·July 16, 2014

    07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Enforcement
    Class II ·Terminated·Vascular Technology, Inc.·July 16, 2014

    07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Enforcement
    Class II ·Terminated·Vascular Technology, Inc.·July 16, 2014

    VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Enforcement
    Class II ·Terminated·Vascular Technology, Inc.·July 16, 2014