28 results
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26ms
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Sources: EU EUDAMED, US FDA
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
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021
BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·May 24, 2017
Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·February 14, 2018
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
CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·June 27, 2012
CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·June 27, 2012
CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 30, 2014
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
FDA Enforcement
Class II
·Completed·Spectrum Medical Ltd.·October 30, 2024
CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 4, 2012
CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 4, 2012
CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 4, 2012
CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 4, 2012
CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 4, 2012