BEUDAMED
    6,102 results · 64ms · Sources: EU EUDAMED, US FDA

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    VDAP

    FDA UDI
    Visibly, Inc.·00850038376000·Visibly Digital Acuity Product (VDAP)

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 10, 2024

    Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·November 4, 2015

    AMBIT PAIN CONTROL SYSTEM, PIB/PCA

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code FRN·September 18, 2023

    Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·February 13, 2013

    VIAL2BAG ADVANCED®  20MM ADMIXTURE DEVICE

    FDA Adverse Event
    Malfunction ·WEST PHARMACEUTICAL SERVICES AZ, INC.·Product code LHI·February 27, 2023

    BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, 8 F, ELBOW

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code BSY·October 12, 2022

    Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Xlumena, Inc.·September 18, 2013

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·November 19, 2025

    EVOLVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH, INC.·Product code IKY·April 1, 2014

    EVOLVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH INC.·Product code IKY·April 1, 2014

    EVOLVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH, INC.·Product code IKY·April 1, 2014

    EVOLVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH, INC.·Product code IKY·April 1, 2014

    EVOLVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH INC.·Product code IKY·April 1, 2014

    EVOLVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH INC.·Product code IKY·April 1, 2014

    EVOLVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH INC.·Product code IKY·April 1, 2014

    EVOLVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH, INC.·Product code IKY·April 1, 2014

    EVOLVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH INC.·Product code IKY·April 1, 2014

    EVOLVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH, INC.·Product code IKY·April 1, 2014

    EVOLVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH INC.·Product code IKY·April 1, 2014