85 results
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·March 19, 2014
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021
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
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
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·February 20, 2019
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·February 20, 2019
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·February 20, 2019
COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·February 20, 2019
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
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
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
Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568 7605-SEC Single Basin Kit 50000599 7694-ADA Single Basin Kit 50007698 7698-T4 Single Basin Kit 50007699 7699-T4 Single Basin Kit
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 29, 2015
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- 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
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
FDA Enforcement
Class II
·Terminated·Datascope Corporation·June 20, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
FDA Enforcement
Class II
·Terminated·Datascope Corporation·June 20, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
FDA Enforcement
Class II
·Terminated·Datascope Corporation·June 20, 2018