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

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    SPIROMETER, MINI POSITIVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Ingenia

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838108684·SmartPath to dStream integrates dStream archite...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111314810·JACKSON IMP TRACH SS W/ADAP #5

    BLOOD FILTER, MICROEMBOLI-ATS-F10

    FDA 510(k)
    FDA Class 2 ·General Hospital

    tün® ultrasonic tips product family

    FDA 510(k)
    FDA Class 2 ·Dental

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 11, 2012

    DERMABOND TOPICAL SKIN ADHESIVE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code MPN·April 30, 2014

    3004123209-2015-00436

    FDA Adverse Event
    Malfunction ·Product code MKJ·April 24, 2015

    Product Name: SmartPath to dStream for 3.0T; Model Number: 782145

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 28, 2025

    SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    SmartPath to dStream for 3.0T Model Number (REF): 782145;

    FDA Enforcement
    Class II ·Ongoing·Philips North America·August 6, 2025

    Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    SmartPath to dStream for 3.0T, Model Number: 782145;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

    SmartPath to dStream for 3.0T, Model Number: 782145;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025

    SmartPath to dStream for 3.0T Model Number (REF): 782145

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    SmartPath to dStream for 3.0T Model Number (REF): 782145;

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·June 30, 2025

    Product Name: SmartPath to dStream for 3.0T; Model Number: 782145

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 13, 2025

    SmartPath to dStream for 3.0T Model Number (REF): 782145

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025