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

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    CRYSTALLESSENCE

    FDA 510(k)
    FDA Class 2 ·Dental

    KY-M280U SURGICAL CAMERA

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 11, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 24, 2014

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    HF-RESECTION ELECTRODE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

    HF-RESECTION ELECTRODE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

    UNKNOWN

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code KNS·October 21, 2022

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024