BEUDAMED
    332 results · 13ms · Sources: EU EUDAMED, US FDA

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    pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).

    FDA Enforcement
    Class II ·Terminated·Sysmex America Inc·November 6, 2013

    pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).

    FDA Recall
    Terminated ·Sysmex America Inc·Product code GKZ·May 15, 2013

    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC

    FDA Recall
    Terminated ·Arrow International Inc·Product code BSO·January 15, 2020

    FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP

    FDA Recall
    Terminated ·Arrow International Inc·Product code BSO·January 15, 2020

    GOVES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 332614 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CE18TK ACCU-BLOC PERIFIX KIT, Material Number 332220 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CONTIPLEX TUOHY SET, 18GX4", 1.3X100MM, Material Number 331693 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    EPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CE18TIN CONT EPIDURAL SET LF, Material Number 332201 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    SCNB4TK CONT STIM W/4 INCH INSUL TUOHY, Material Number 331756 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CEP20TO CONT EPID PEDIATRIC SET, Material Number 332293 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CE17TKF PERIFIX CONTIN. EPIDURAL TRAY, Material Number 332086 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CE18TKST CONT EPID W/SOFT TIP, Material Number 332081 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    EC20CS EPIDURAL CATHETER, Material Number 333532 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018