BEUDAMED
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    CEMEX SYSTEM GUN APPLICATION VERSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Essential Kit

    FDA UDI
    MEDIVATORS INC.·40677964008663·Essential Kit includes Olympus DEFENDO Valves, ...

    MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DRG AURICA ELISA TESTOSTERONE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SINGLE USE PRELOADED SPHINCTEROTOME V

    FDA Adverse Event
    Malfunction ·OLYMPUS VIETNAM CO. LTD.·Product code KNS·March 12, 2026

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013

    UNKNOWN ZIMMER MIS TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·February 18, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 12, 2014

    VELOCITY DELIVERY MICROCATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DQY·September 24, 2015

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·September 24, 2015

    QDOT MICRO¿ CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code OAE·May 9, 2025

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024