BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DW 273 #1

    FDA 510(k)
    FDA Class 2 ·Dental

    VARIFLEX

    FDA 510(k)
    FDA Class 2 ·Dental

    PERSONA STEMMED NATURAL TIBIA

    FDA Adverse Event
    Injury ·ZIMMER·Product code JWH·May 1, 2013

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·September 16, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 12, 2011

    LASSOSTARNAV,10P,15MM DIA LOOP

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·February 22, 2023

    LASSOSTAR CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020

    LASSOSTAR NAV CIRCULAR MAPPING CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·November 23, 2022

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015