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

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    PRESSUREALERT® Pressure Monitoring System

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Al-Rad Companion (Pulmonary)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ABB VIE J

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

    LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 1

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·August 28, 2012

    IMPLANT, ENDOSSEOUS, ROOT-FORM

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·August 28, 2025

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 26, 2011

    OPTIFLOW JUNIOR INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAT·July 18, 2013

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025