BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    DRIVER/EXTRACTOR

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818087020183·Fixed Curve Duo-Decapolar Catheter with Guidewi...

    TORQMAX SHEATH GRIP ACCESSORY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IKX·June 30, 2014

    ACTICON NEOSPHINCTER

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·January 2, 2013

    RUGGED AMB COT-DX

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIV·Product code FPO·November 12, 2010

    TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z

    FDA Enforcement
    Class II ·Ongoing·Acclarent, Inc.·December 29, 2021

    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