5 results
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20ms
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Sources: EU EUDAMED, US FDA
DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 13, 2019
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 1, 2022
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics P.E.I. Inc.·February 1, 2017
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·September 20, 2017
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics P.E.I. Inc.·March 23, 2016