BEUDAMED
    229 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath shaft material with a soft tip and a Check-Flo¿ fitting at the proximal end. The sheath is accompanied by a dilator for access to the body as a catheter over the wire guide.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 29, 2015

    Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/12cm, CUTLMY501JRSCCCT, G26945, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/15cm, CUTLMY501JLSCCCT, G26943, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 5.0Fr/8cm, CUDLMY501JCCT, G26934 Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 5.0Fr/12cm, CUDLMY501JRSCCCT, G26937 Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/8cm, CUTLMY501JCCT, G26941, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Cook Medical Central Venous Catheter Tray, 5 Lumen Polyurethane, 10Fr/20cm, CUQLMY1001JRSCCCT, G32394, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/8cm, C-UDLMY-401J-CCT, G26927, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/12cm, C-UDLMY-401J-RSC-CCT, G26932, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Cook Medical Central Venous Catheter Tray, 5 Lumen Polyurethane, 10Fr/15cm, C-UQLMY-1001J-CCT, G32392, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Cook Spectrum PICC Tray, Minocycline/Rifampin Impregnated, Silicone Peripherally Inserted Central Venous Catheter, 5.0Fr/60cm, PICSY501MPISABRM, G36222, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 47402 - not on label)

    FDA Recall
    Terminated ·Cook, Inc.·Product code DQX·August 15, 2007

    Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double Lumen, 7.5Fr/20cm, CUDLMY751JRSCABRMFST, G13482, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double Lumen, 9.5Fr/15cm, CUDLMY953JABRMFST, G13481, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Central Venous Tray, Triple Lumen Polyurethane, 9.0 Fr/ 15cm, C-UTLMY-901J-CCT-RD, G48997, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Arterial Pressure Monitoring Tray, 2.5 Fr/ 2.5 cm Polyethylene Catheter,C-PMSY-250-HOPKINS, G44036, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code LJS·October 4, 2010

    Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 7.5Fr/20cm, CUDLMY751JRSCABRMFSTA, G29518, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen Polyurethane, 10.0Fr/25cm, CUQLMY1001JLSCABRMFSTA, G43135, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Central Venous Catheter Tray, Polyurethane Catheter, 3.0 Fr/ 8 cm, C-PUMY-301J-CHILDRENS-HCT, G44042, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Central Venous Catheter Tray, Polyurethane Catheter, 4.0 Fr/ 9cm, C-PUMY-401J-CHILDRENS-A-HCT, G44044, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010