BEUDAMED
    94 results · 27ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·December 26, 2018

    Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·December 26, 2018

    Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018

    Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210, packaged 1/box, 12 boxes/case, single use, RX, Sterile. .

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018

    Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Manufactured For Cardinal Health, Waukegan, IL.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018

    Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018

    Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·August 30, 2017

    Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018

    Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018

    Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018

    Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018

    Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018

    Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018