BEUDAMED
    18 results · 30ms · Sources: EU EUDAMED, US FDA

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    BD SPRING BASED SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·September 3, 2021

    IMPACT-PLUS

    FDA UDI
    Denplus Inc·D8451011103·IMPACT-PLUS, RPI, 454 g

    Pro Clean

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783003826·PRO CLEAN STAIN CLEANER (SINGLE BOX of 25)

    DR 17e C

    FDA UDI
    AGFA·05414904233290·DR Detector

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0110130·Sounder, Ball Tip, Straight, Soft, Titanium

    SURSHIELD WINGED INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    POLARIS 5.5 SYSTEM IMPLANTS

    FDA Adverse Event
    Malfunction ·EBI, LLC·Product code NKB·August 29, 2011

    POLARIS 5.5 SYSTEM IMPLANTS

    FDA Adverse Event
    Malfunction ·EBI, LLC·Product code KWQ·August 29, 2011

    SPF MINI

    FDA Adverse Event
    Malfunction ·EBI, LLC·Product code LOE·August 29, 2011

    BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 7, 2022

    ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·March 14, 2013

    CAPD DISCONNECT Y SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 8, 2011

    QUICKSITE LV

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021