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

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    SJM RIGID SADDLE RING MODEL RSAR-(SIZE)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3-Lead Leadset,Adt/Ped,AHA,Snap

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904004563·

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735468584·ECG Monitor Lead Wire Mindray Style

    ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106

    FDA 510(k)
    FDA Class 2 ·Neurology

    CLEARFIL NEW BOND

    FDA 510(k)
    FDA Class 2 ·Dental

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 6, 2021

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·March 31, 2016

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·May 7, 2020

    FLEXI-SEAL FMS

    FDA Adverse Event
    Other ·CONVATEC·Product code KNT·June 7, 2006

    5.0 CM SHORT ATTACHMENT

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    ADVIA 2120I

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code GKZ·April 6, 2011

    FLEXI-SEAL FECAL MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·CONVATEC INC.·Product code KNT·October 20, 2016

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 17, 2021

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    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 GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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