6 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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ARROW Endurance Extended Dwell Peripheral Catheter System
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 20, 2022
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 20, 2022
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
FDA Enforcement
Class II
·Ongoing·Diagnostica Stago, Inc.·June 25, 2025
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025