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

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    NOVABONE-BIOACTIVE SYNTHETIC GRAFT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704920904·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284423·WEITLANER RETRACTOR 4" BLUNT

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776315139·Weitlaner Retractor

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450140482·

    HOME CARE JELLY

    FDA 510(k)
    FDA Class 2 ·Neurology

    PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013

    CLEARVIEW HCG COMBO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·March 15, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    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