6 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 1, 2017
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
FDA Enforcement
Class I
·Terminated·Deroyal Industries, Inc. Lafollette·October 6, 2021
In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2).
FDA Recall
Terminated
·Abbott Health Products, Inc. Hwy 2 Km 58.0 Cruze Davila·Product code MGU·March 23, 2005
Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
FDA Recall
Terminated
·CORENTEC CO., LTD Seobuk-gu 12 Yeongsanhong 1-gil Seobuk-gu, Cheonan-si Korea (the Republic of)·Product code LPH·February 27, 2017
DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
FDA Recall
Terminated
·Coltene Whaledent AG Feldwiesenstrasse 20 Altstatten Sg Switzerland·Product code EJL·July 19, 2019