BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    VARIOunite

    FDA 510(k)
    FDA Class 2 ·Dental

    Monza Cervical Plate System

    FDA UDI
    Altus Spine, LLC·B41711602441·44mm Cervical Plate, 2 Level

    SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    METRO SOFT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 16, 2020

    GORE DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·October 19, 2020

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DYB·October 6, 2016

    SOFTCLIX® LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 13, 2011

    ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 10, 2013

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 7, 2024

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·May 30, 2023

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025