BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673181·LEVAMED STABILI-TRI ANK BLU R II

    JAS CARBON DIOXIDE LIQUID REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056301·Zirlux Multi Anterior A3,98.5X22

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033380055·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033380062·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033380048·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033380079·

    WAKO IMMUNOASSAY CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EEG SPIKE AND EVENT DETECTOR MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    V.A.C. THERAPY

    FDA Adverse Event
    Injury ·KCI USA INC.·Product code OMP·June 23, 2014

    V.A.C. THERAPY

    FDA Adverse Event
    Injury ·KCI USA INC.·Product code OMP·June 23, 2014

    V.A.C. DRESSING

    FDA Adverse Event
    Injury ·KCI USA INC.·Product code OMP·June 23, 2014

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Death ·NXSTAGE MEDICAL, INC.·Product code KDI·March 15, 2013

    LEGEND FOOTED ATTACHMENT

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·March 9, 2011

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEURMODULATION CORP·Product code LGW·February 12, 2008

    V.A.C. THERAPY

    FDA Adverse Event
    Injury ·KCI USA INC.·Product code OMP·June 23, 2014

    EVOLUT FX VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

    ENCOREANYWHERE

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 17, 2016

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019