BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    ALARA Neuro Access Kit

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306812156·Fomon Retractor, Single Ball, 16cm / 6.25 in

    NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 2, 2018

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·August 29, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 19, 2025

    PROSTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code KNS·October 3, 2008

    PALINDROME HSI 28/45 KIT VT CE

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MPB·June 10, 2013

    OSTEOFIL RT DBM PASTE

    FDA Adverse Event
    Injury ·REGENERATION TECHNOLOGIES, INC.·Product code MQV·February 27, 2007

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025

    SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024