10 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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rezum
FDA UDI
NXTHERA, INC.·00855357006010·Delivery Device Kit for BPH
Rezūm Accessory Kit
FDA UDI
NXTHERA, INC.·00855357006034·
REZUM DELIVERY DEVICE KIT FOR BPH
FDA Adverse Event
Injury
·NXTHERA INC.·Product code KNS·December 21, 2018
REZUM DELIVERY DEVICE KIT FOR BPH
FDA Adverse Event
Injury
·NXTHERA INC.·Product code KNS·December 17, 2018
REZUM DELIVERY DEVICE KIT FOR BPH
FDA Adverse Event
Injury
·NXTHERA INC.·Product code KNS·December 18, 2018
REZUM DELIVERY DEVICE KIT FOR BPH
FDA Adverse Event
Injury
·NXTHERA INC.·Product code KNS·December 17, 2018
REZUM DELIVERY DEVICE KIT FOR BPH
FDA Adverse Event
Injury
·NXTHERA INC.·Product code KNS·December 10, 2018
REZUM DELIVERY DEVICE KIT FOR BPH
FDA Adverse Event
Injury
·NXTHERA INC.·Product code KNS·April 5, 2017
Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to 50 years of age with a prostate volume greater than or equal to 30cm3 and less than or equal to 80cm3. The Rezum System is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe.
FDA Recall
Terminated
·NXTHERA·Product code KNS·July 28, 2017
Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to 50 years of age with a prostate volume greater than or equal to 30cm3 and less than or equal to 80cm3. The Rezum System is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe.
FDA Enforcement
Class II
·Terminated·NXTHERA·December 27, 2017