BEUDAMED
    38 results · 12ms · Sources: EU EUDAMED, US FDA

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    Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGL·August 11, 2008

    CCX Operating Software , Version 4.08

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·January 27, 2006

    Stat Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·January 27, 2006

    Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·January 27, 2006

    Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Stat Profile Critical Care Xpress CCX+ (R) Anaylzer Catalog NUmber: 37555 R= Refurbished

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Stat Profile Critical Care Xpress CCX (R) Analyzer Catalog Number: 37562 R= Refurbished

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

    FDA Recall
    Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

    Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes

    FDA Recall
    Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

    Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

    FDA Recall
    Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

    Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400

    FDA Recall
    Terminated ·Aspen Surgical Products, Inc.·Product code CCX·July 23, 2021

    Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery.

    FDA Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code CCX·November 27, 2007

    Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100

    FDA Recall
    Terminated ·Aspen Surgical Products, Inc.·Product code CCX·July 23, 2021

    Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.

    FDA Recall
    Terminated ·Covidien LLC·Product code CCX·May 8, 2014

    Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery Catalog Numbers: A-70700 and A-70701-2

    FDA Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code CCX·November 16, 2011

    Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300

    FDA Recall
    Terminated ·Aspen Surgical Products, Inc.·Product code CCX·July 23, 2021

    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

    FDA Enforcement
    Class III ·Terminated·AGFA Healthcare Corp.·August 20, 2014

    Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 7, 2019

    Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 7, 2019