BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    56MM AND R3 ACETABULAR SHELL

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

    DELTRAN IV PLUS

    FDA Adverse Event
    Malfunction ·UTAH MEDICAL PRODUCTS, INC.·Product code DRS·January 26, 2010

    ACTICLOT PROTEIN S, MODEL 843L

    FDA 510(k)
    FDA Class 2 ·Hematology

    POCKETCHEM UA AUTION STICKS 10TA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AQUASIL ULTRA

    FDA Adverse Event
    Injury ·DENTSPLY CAULK·Product code ELW·April 30, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 6, 2014

    MX PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL KALAMAZOO·Product code FPO·May 3, 2011

    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