BEUDAMED
    48 results · 22ms · Sources: EU EUDAMED, 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·April 5, 2017

    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 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 TO BPH

    FDA Adverse Event
    Injury ·NXTHERA (A BOSTON SCIENTIFIC COMPANY)·Product code KNS·June 18, 2019

    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

    ExThera Medical Corporation

    Manufacturer
    🇺🇸 United States·1 Importer

    EXTHERA MEDICAL CORPORATION

    FDA registration
    EXTHERA MEDICAL CORPORATION·1 product·🇺🇸 United States

    SERAPH 100

    FDA Adverse Event
    Injury ·EXTHERA MEDICAL CORPORATION·Product code QLO·August 26, 2025

    PROTECTA XT DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2013

    VIBRANT SOUNDBRIDGE

    FDA Adverse Event
    Malfunction ·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MAH·February 8, 2006

    SERAPH 100

    FDA Adverse Event
    Death ·EXTHERA MEDICAL CORPORATION·Product code QLO·May 2, 2025

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 11, 2018

    SERAPH 100 MICROBIND AFFINITY BLOOD FILTER

    FDA Adverse Event
    Injury ·EXTHERA MEDICAL CORPORATION·Product code FLD·May 18, 2021

    SERAPH 100

    FDA Adverse Event
    Injury ·EXTHERA MEDICAL CORPORATION·Product code QLO·August 26, 2025