BEUDAMED
    21 results · 37ms · Sources: EU EUDAMED, US FDA

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    ECHELON SPECTROSCOPY PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481113345·LOCATOR R-Tx Abutment for Ankylos Connection Im...

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70715061·Starter-assortment 2D Lingual acc. Dr. Biondi

    LOCATOR R-Tx, Dentsply Sirona System

    FDA UDI
    Zest Anchors, LLC·00840481132469·Ankylos LOCATOR R-Tx Abutment C/ 6mm

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481119569·LOCATOR F-Tx Abutment for Anklos Connection Imp...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065777·INTRAORAL ELASTICS 6,5 oz 1/8" brown

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481129377·LOCATOR R-Tx Abutment, Ankylos Conical Connecti...

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 20, 2019

    OMNILINK .035 BILIARY STENT SYSTEM

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

    POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 11, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2025

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·April 22, 2013

    UNKNOWN DEPUY 54X28 DURALOC LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 15, 2011

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 2, 2008

    Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063

    FDA Recall
    Terminated ·Rubicor Medical·Product code GEI·February 17, 2006

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022