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Sources: EU EUDAMED, US FDA
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AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code NEY·April 17, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code NEY·April 17, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code NEY·April 17, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019
Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
FDA Enforcement
Class II
·Terminated·Angiodynamics, Inc.·September 15, 2021
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
FDA Enforcement
Class II
·Terminated·Angiodynamics, Inc.·September 15, 2021
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
FDA Enforcement
Class II
·Terminated·Angiodynamics, Inc.·September 15, 2021
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code NEY·April 17, 2019
Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
FDA Enforcement
Class II
·Terminated·Angiodynamics, Inc.·September 15, 2021
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code NEY·July 20, 2021
Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code NEY·July 20, 2021
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code NEY·July 20, 2021
Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code NEY·July 20, 2021
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code NEY·April 17, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019
Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.
FDA Enforcement
Class II
·Terminated·Estill Medical Technologies, Inc·October 29, 2014
Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.
FDA Recall
Terminated
·Estill Medical Technologies, Inc·Product code BSB·July 25, 2014