BEUDAMED
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    UNKNOWN

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

    TVT EXACT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·April 19, 2023

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·September 5, 2022

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·March 15, 2017

    UNKNOWN_VARIPULSE

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code QZI·December 2, 2025

    UNK_QDOT MICRO

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code OAE·August 24, 2023

    SAPPHIRE M.T INFUSION PUMP - SPANISH

    FDA Adverse Event
    Malfunction ·Q CORE MEDICAL LTD.·Product code FRN·November 23, 2016

    Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA; Distributed by Roche Diagnostics Indianapolis, IN 46266 USA; 03610179001. For use with Light Cycler 2.0 instrument; The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 Instrument using the LightCycler Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NPQ·March 31, 2011

    RIST

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code PND·March 31, 2025

    640G INSULIN PUMP MMT-1711K

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 21, 2020

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·April 25, 2025

    EASYPUMP 2

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code MEB·November 1, 2023

    Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA DisFor use with Light Cycler 2.0 instrument; The Factor II (Prothrombin) G20210A Kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor II DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (Prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 Instrument using the Roche Confidential Page 3 of 9 LightCycler Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.tributed by Roche Diagnostics Indianapolis, IN 46256 USA; 03610195001

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JPF·March 31, 2011

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    Vortran Medical Technology 1 Inc.

    Manufacturer
    🇺🇸 United States·3EC International a.s.

    COMPANION 41

    FDA Adverse Event
    Injury ·CAIRE INC.·Product code BYJ·May 19, 2020

    VORTRAN MEDICAL TECHNOLOGY 1, INC.

    FDA registration
    VORTRAN MEDICAL TECHNOLOGY 1, INC.·5 products·🇺🇸 United States

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    FDA Adverse Event
    Injury ·MANNKIND CORPORATION - V-GO·Product code LZG·June 24, 2022

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·August 5, 2016

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code KYF·July 14, 2022