6 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·July 24, 2019
HEMO-10 Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·February 4, 2020
HEMO-7 Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·February 4, 2020
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