5 results
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9ms
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Sources: EU EUDAMED, US FDA
Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set, 9104444 ATF-120 Fast Start Kits (AT-3), or 9108444 ATF-40 Fast Start Kits AT-3) Product Usage: The Fresenius Kabi CATSmart device (Continuous auto transfusion System) is indicated for the processing of autologous shed blood collected interaoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. The CATSmart Auto transfusion System is designed to reduce the need for allogeneic blood transfusion by re-infusing a patient s own lost blood during surgery. The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous re-infused blood (auto transfusion). This is a single-use device.
FDA Enforcement
Class II
·Terminated·Fenwal Inc·May 1, 2019
Olympus Pleuravideoscope, Model LTF-160
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·April 29, 2020
Olympus Pleuravideoscope, Model LTF-240
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·April 29, 2020
Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
SurFlo IV Catheter
FDA Enforcement
Class II
·Terminated·Terumo Medical Corporation·May 10, 2017