BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09

    FDA 510(k)
    FDA Unclassified ·Unknown

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 18, 2013

    UNKNOWN PREFILL

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code NZW·April 23, 2011

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

    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 VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024