6 results · 12ms · Sources: EU EUDAMED, US FDA

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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