BEUDAMED
    1,135 results · 33ms · Sources: EU EUDAMED, US FDA

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    (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·December 23, 2020

    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

    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

    CCX Operating Software , Version 4.08

    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 PLUS (CCX) Analyzer Catalog Number: 37413

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

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

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTZ·June 14, 2019

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

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTZ·June 14, 2019

    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

    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

    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

    (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTZ·November 11, 2020

    Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·April 13, 2004

    Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·November 4, 2004