BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLATEK FOAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    FIESTA IMAGING OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMP,1-PC,ANG,3.0X13MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 19, 2024

    IMP,1-PC,ANG,3.0X13MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 11, 2019

    1.8MM TI LOCKING SCREW

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWP·April 17, 2013

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 16, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·June 18, 2008

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013

    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