BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    SPEEDICATH COMPACT

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

    Integra® Spider™ Limted Wrist Fusion System

    FDA UDI
    INTEGRA LIFESCIENCES CORPORATION·10381780064817·The Integra Spider Limited Wrist Fusion bone sc...

    ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 29, 2024

    SPECTRA WAVEWRITER?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 20, 2025

    D131 KIDS INFANT ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·May 20, 2026

    COULTER® AC T 5DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·April 23, 2013

    MAXIMO VR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·July 10, 2008

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·April 29, 2011

    D131 KIDS INFANT ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL.·Product code DTM·September 26, 2024

    D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·June 18, 2019

    D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE

    FDA Adverse Event
    SORIN GROUP ITALIA·Product code DTM·February 3, 2016

    LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Recall
    Terminated ·Zest Anchors LLC·Product code DZE·January 16, 2014

    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Enforcement
    Class II ·Terminated·Zest Anchors LLC·February 12, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015