89 results
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Sources: EU EUDAMED, US FDA
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Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.
FDA Recall
Terminated
·Helena Laboratories, Inc.·Product code JPB·April 20, 2016
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
FDA Recall
Terminated
·Helena Laboratories, Inc.·Product code JPB·February 24, 2017
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
daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·May 14, 2007
Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DTQ·June 4, 2007
Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
FDA Recall
Terminated
·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021
BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
FDA Recall
Terminated
·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code KNW·March 22, 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 Recall
Terminated
·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DWF·January 3, 2018
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
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
FDA Recall
Terminated
·AtriCure, Inc.·Product code OCL·January 22, 2019