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

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    Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Synthes GmbH·10886982145154·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...

    Disposable Iris Retract

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114346·FLEXIBLE IRIS RETRACTORS 5 PKS of 5

    FRSENIUS PD IQCARD CYCLER

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

    ASCENSION SILLICONE MCP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    3CCD DIGITAL CAMERA CONTROLLER NTSC/PAL

    FDA Adverse Event
    Malfunction ·CONMED LINVATEC·Product code FWF·September 26, 2008

    ELEVESS

    FDA Adverse Event
    Other ·ANIKA THERAPEUTICS, INC.·Product code LMH·October 17, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 2, 2013

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020