BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    SILVERFIL

    FDA 510(k)
    FDA Class 2 ·Dental

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00531141·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450407875·

    EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00813939023732·EndoVive Gastrostomy Tube, Right Angle, with EN...

    NUMED TYSHAK AND Z-MED PTV CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BCS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    EXPRESS? LD VASCULAR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·April 11, 2013

    INSIGNIA PLUS

    FDA Adverse Event
    Death ·Product code DXY·May 28, 2008

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 13, 2011

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011

    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