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

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    MICROMYST APPLICATOR, MODEL 20-5000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    nSpire Health

    FDA UDI
    NSPIRE HEALTH, INC.·10852417003672·KoKo Standard Pulmonary Function Filter, White ...

    BREAS HA50 HUMIDIFIER, MODEL HA50

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    H 105700#TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·May 5, 2015

    HQV 32902#INTEGRATED ADULT PACK

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·June 22, 2015

    SINGLE EXTENSION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·April 16, 2013

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 10, 2011

    JAPANESE OMNIFIT EON CS 132 NKSIZE 9 STEM 40 MM 13

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code KWY·July 22, 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