BEUDAMED
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    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065746·INTRAORAL ELASTICS 6,5 oz 1/4" red

    SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONMED

    FDA UDI
    Conmed Corporation·10845854007099·SIDECUTTING BUR, MEDIUM, TAPERED, 2 X 7.5 MM

    NA

    FDA UDI
    STERILMED, INC.·10888551018005·BUR CARBIDE MICRO SIDE CUTTING TAPERED MEDIUM 6...

    icotec Pedicle System 6.0, Rod, Ti, Curved, Ø 6.0 r120 x 060 mm

    FDA UDI
    icotec AG·07640164848686·icotec Pedicle System 6.0, Rod, Ti, Curved, Ø ...

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112060·Tap, 6.50mm

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112060·Tap, 8.5 mm

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0112060·Punch, 6 and 8 mm

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES

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

    IMMULITE 2000 SPECIFIC ALLERGENS

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    CLINITEK STATUS+

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JHI·December 2, 2019

    PANORAMA CENTRAL STATION

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·September 16, 2014

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·April 20, 2011

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·October 14, 1997

    ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.

    FDA Recall
    Terminated ·Product code FGE·March 8, 2006

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 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