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

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    EnFocus 2300, EnFocus 4400

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Oticon

    FDA UDI
    Oticon A/S·05707131282132·NERA2 PRO TI, BTE 13 WL 85 STG

    RPS ADENO DETECTOR PLUS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TELAVANCIN 30 UG, BBL SENSI-DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RINGLOC-X E1 H/W 56/32MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·April 11, 2025

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 6, 2013

    ECHELON*FLEX60 COMPACT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 6, 2011

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·February 7, 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