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    Factor Medical Inc.

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·2 Devices

    FACTOR MEDICAL, INC

    FDA registration
    FACTOR MEDICAL, INC·1 product·🇺🇸 United States

    FACTOR MEDICAL Inc.

    FDA registration
    FACTOR MEDICAL Inc.·1 product·🇺🇸 United States

    BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR

    Device
    EU MDR · Eu Md Class 2a ·Factor Medical Inc.·On the market·1 country

    BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR

    Device
    EU MDR · Eu Md Class 2a ·Factor Medical Inc.·On the market·1 country

    Selphyl PRFM Tube

    FDA UDI
    Factor Medical, Inc.·00851802007120·Blood separation tube for PRFM

    SELPHYL®

    FDA UDI
    Factor Medical, Inc.·10851802007035·The SELPHYL® System is designed for the safe an...

    SELPHYL®

    FDA UDI
    Factor Medical, Inc.·10851802007004·The SELPHYL® System is designed for the safe an...

    SELPHYL®

    FDA UDI
    Factor Medical, Inc.·10851802007097·The SELPHYL® System is designed for the safe an...

    SELPHYL®

    FDA UDI
    Factor Medical, Inc.·10851802007028·The SELPHYL® System is designed for the safe an...

    SELPHYL®

    FDA UDI
    Factor Medical, Inc.·10851802007059·The SELPHYL® System is designed for the safe an...

    Selphyl PRP Tube

    FDA UDI
    Factor Medical, Inc.·00851802007113·Blood separation tube for PRP

    SELPHYL®

    FDA UDI
    Factor Medical, Inc.·10851802007103·The SELPHYL® System is designed for the safe an...

    SELPHYL®

    FDA UDI
    Factor Medical, Inc.·10851802007042·The SELPHYL® System is designed for the safe an...

    SELPHYL PRP Tube

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Factor Medical Inc.·2 devices

    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

    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

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·February 27, 2019

    DISTAL ACCESS CATHETER 070

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL, INC.·Product code DQY·February 8, 2012

    BCS XP SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GKP·December 7, 2017