BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    AIRNERGY+STREAM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284409·WEITLANER RETRACTOR 4" SHARP

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704920898·

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776315122·Weitlaner Retractor

    KADANCE 2000

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIMPLICITY SOFT INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·September 3, 2010

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 11, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 2, 2014

    KRONOX LV-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·March 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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015