BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    MICRO-STRIP FOR PHENCYCLIDINE METABOLITES

    FDA 510(k)
    FDA Unclassified ·Unknown

    Rezum System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COR12+

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 7, 2026

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    SYNCHRON® ALT REAGENT, 2 X 200 TEST

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CKA·July 26, 2011

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·March 6, 2013

    INSERTER

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code MQP·February 15, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

    FDA Recall
    Terminated ·Bard Access Systems·Product code FJS·May 21, 2011

    SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE

    FDA Adverse Event
    Malfunction ·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020