BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    COSMED QUARK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CARESTREAM DRX-EVOLUTION

    FDA UDI
    CARESTREAM HEALTH, INC.·60889978001170·DRX-EVOLUTION/P-PCSH-P-X

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001174·artVeneer life upper anteriors, BOS, B1

    CALLCORD,12FT,COOL GRAY 6C,1/4",DUAL,A

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828100106·CALLCORD,12FT,COOL GRAY 6C,1/4",DUAL,A

    KerraMax Care Gentle Border

    FDA UDI
    CRAWFORD HEALTHCARE LIMITED·05060077234147·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971369·

    3M QUIK TEMP TEMPORIZATION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    ACTION AF-1 WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PICC NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007

    PICC NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·March 13, 2013

    JAPANESE SV 2.5 INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·February 24, 2011

    AUTODISC 50 TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2008

    PICC-NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS·Product code DQO·April 28, 2004

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012