BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NEOPOP INFANT RESUSCITATOR WITH FLOW METER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPI SYSTEM DENTAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 19, 2018

    NEXGEN LPS ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·July 20, 2011

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013

    DA VINCI SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code NAY·September 12, 2008

    PANTHER FUSION ADV/HMPV/RV ASSAY

    FDA Adverse Event
    Injury ·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021

    Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620 SOMATOM go.Up Model 11061628 NA* SOMATOM go.All Model 11061630 SOMATOM go.All Model 11061638 NA* SOMATOM go.Top Model 11061640 SOMATOM go.Top Model 11061648 NA* SOMATOM X.cite Model 11330001 SOMATOME X.ceed Model 11330002 SOMATOM go.Sim Model 11061660 NA* SOMATOM go.Open Pro Model 11061670 NAEOTOM Alpha Model 11330003

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 1, 2023