BEUDAMED
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    THINKINGNET

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743458·LEVAMED ANKLE SUPPORT SILVER I

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102110·Shaver, Open 11mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024007·PADDLE SPREADER, 17MM

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023949·PADDLE SPREADER, 11MM

    HARDYDISK, SULFA/TRIMETH

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SAMARCO SPIDER PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD SYRINGE 5ML LL BNS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·September 11, 2024

    IV SET SN404 W/O BP Y-CONN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·December 4, 2020

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    CRYSTALENS HD IOL

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code NAA·March 13, 2013

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·March 1, 2011

    UNKNOWN

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code OWT·July 2, 2019

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA·Product code NIQ·December 13, 2010

    BD INSYTE¿ AUTOGUARD¿ IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 15, 2023

    BD INSYTE¿ AUTOGUARD¿ IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 30, 2023

    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

    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