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

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    BC Reflex Uni Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TORQTECH

    FDA 510(k)
    FDA Class 1 ·Dental

    STERI-MATE STERILIZABLE HANDPIECE

    FDA 510(k)
    FDA Class 2 ·Dental

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 11, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 10, 2013

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 9, 2008

    M3151 INFORMATION CENTER CLIENT REL N.0

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·June 24, 2013

    SYNCRA CRT-P

    FDA Adverse Event
    Malfunction ·MEDTRONIC S.A.·Product code NVZ·August 11, 2011

    LINER PROVISIONAL

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HWT·November 5, 2018

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 14, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 25, 2018

    FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005

    FDA Recall
    Terminated ·Respironics Novametrix, LLC.·Product code BZK·July 29, 2011

    Philips FloTrak Elite modules: FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations.

    FDA Recall
    Terminated ·Respironics Novametrix, LLC.·January 4, 2011

    PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, Refurbished Part Number : U1051674 PHILIPS NM3 Monitor, English, Demo Unit Part Number: DU1051674 PHILIPS NM3 Monitor, Spanish Part Number: 1060462 PHILIPS NM3 Monitor, French Part Number: 1060458 PHILIPS NM3 Monitor, Swedish Part Number:1062860 Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate.

    FDA Recall
    Terminated ·Respironics Novametrix, LLC.·Product code BZK·July 29, 2011

    Philips NM3 Monitors, Model 7900 PHILIPS NM3 Monitor, English - P/N 1051674 PHILIPS NM3 Monitor, English Refurbished - P/N U1051674 PHILIPS NM3 Monitor, English, Demo Unit - P/N DU1051674 PHILIPS NM3 Monitor, Spanish - P/N 1060462 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations.

    FDA Recall
    Terminated ·Respironics Novametrix, LLC.·January 4, 2011

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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