BEUDAMED
    26 results · 25ms · Sources: EU EUDAMED, US FDA

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    DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INPUT™ PS

    FDA UDI
    MEDTRONIC, INC.·00643169014145·INTRDCR 873311 7F 5PK 7F 11CM INPUT

    O.I.C. TITANIUM

    FDA UDI
    Stryker Corporation·07613327262032·DISTRACTOR REAMER

    OSTEOTRANS-OT PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARTHRO-Pump PA304

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 13, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 18, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 13, 2012

    Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code CBK·October 11, 2011

    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

    Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code CBK·June 10, 2010

    DreamStation Auto. Non-Continuous Ventilator.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code BZD·June 30, 2025

    DreamStation Auto BiPAP. Non-Continuous Ventilator.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code BZD·June 30, 2025

    DreamStation Auto CPAP. Non-Continuous Ventilator.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code BZD·June 30, 2025

    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

    Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code CBK·April 27, 2012

    Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA2110X15B IN2100X15B IN2100X19 IN2110X15B IT2100X21B IT2110X21B JP2100X16B JP2110X16B KR2110X15B LA2100X15B LA2110X15B ND2110X15B RDE2100X13B RDE2110X13B RDS2110X11B RIN2100X15B RIN2110X15B RJP2100X16B RJP2110X16B UDS2110X11B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·November 27, 2023

    Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code MNS·August 26, 2022

    Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code MNS·August 26, 2022

    Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code MNS·August 26, 2022