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

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    SCALPEL

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

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M3848134220·Drill Bit - Ø1.2 mm x 4.5 mm

    Prime Medical LLC

    FDA UDI
    Prime Medical LLC·00850055249257·PrimePadPlus-K1-3422

    CARDIQ FUNCTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    M2A 1 PC SHELL 38MMX52MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 15, 2014

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    PUMP MMT-523NAB PRDGM INSULIN BLUE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 20, 2010

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019

    Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;

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

    Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;

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

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 13, 2018

    SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 6, 2024

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 2, 2022

    Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;

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

    Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;

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

    Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

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

    Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

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