BEUDAMED
    19 results · 51ms · Sources: EU EUDAMED, US FDA

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    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 30, 2019

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·March 22, 2018

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·March 30, 2018

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·April 20, 2018

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·May 7, 2019

    Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code GKZ·June 1, 2012

    Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code GKZ·June 1, 2012

    Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code GKZ·June 1, 2012

    Medical Technology Promedt Consulting GmbH

    Authorized representative
    🇩🇪 Germany·194 Manufacturers·10009 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    MedEnvoy Global BV

    Importer
    🇳🇱 Netherlands·234 Manufacturers