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

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    MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Acapella One

    FDA UDI
    Choice Spine, LP·00840996151054·ACAPELLA,TRIAL,PA,NS,14X16X8

    MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    BLAINE SCARCARE PATCH

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    4 FR SL POWERPICC SOLO CATHETER, BASIC

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD)·Product code LJS·April 11, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 4, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 18, 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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015