7 results
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7ms
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Sources: EU EUDAMED, US FDA
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·July 14, 2021
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.
FDA Enforcement
Class II
·Terminated·Hans Pausch Rontgengeratebau Gmbh·June 7, 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
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
Presource PBDS, Kit, Common 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
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
FDA Enforcement
Class II
·Terminated·LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC·March 7, 2018