BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    VIELLE LUBRICANT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TC-PLUS POROUS TIBIAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DR180-II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GRAFTON DBM

    FDA Adverse Event
    Injury ·MEDTRONIC EATONTOWN·Product code NUN·July 6, 2019

    SENSIA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code NVZ·April 10, 2013

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·April 6, 2011

    SYNCHROMED II

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 21, 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 2110. 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