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

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    INBODY, MODELS: 270, R20, R20B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYRINGE 0.5ML 31GA 6MM 10BAG 500CS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 23, 2020

    BIOSENSORS CENTRAL VENOUS CATHETER KITS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    56MM AND R3 ACETABULAR SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 5, 2011

    ARMADA 14 PTA CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LIT·May 3, 2013

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code CBK·August 20, 2014

    CAP FOR INJECTOR MEMBRANE M50

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·May 4, 2021

    ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CEM·January 12, 2011

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012