5 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·October 23, 2024
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
FDA Enforcement
Class I
·Ongoing·Medtronic Perfusion Systems·April 7, 2021
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
FDA Enforcement
Class II
·Ongoing·Cook Biotech, Inc.·October 2, 2024
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667
FDA Enforcement
Class II
·Ongoing·Cook Biotech, Inc.·October 2, 2024
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 16, 2025