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

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    CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX

    FDA Adverse Event
    Death ·ATRICURE, INC.·Product code OCL·November 13, 2018

    SPLITFIX-PL 2 L40 TI

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code JEY·April 29, 2013

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·May 9, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC INC.·Product code NQP·July 24, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018