BEUDAMED
    19 results · 42ms · Sources: EU EUDAMED, US FDA

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    GOTOP Medical, Inc.

    Manufacturer
    🇺🇸 United States

    GOTOP MEDICAL INC

    FDA registration
    GOTOP MEDICAL INC·1 product·🇺🇸 United States

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·00854759007052·Dis, Leg Strap, 12 Pk

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·00854759007090·Flash Drive Assembly

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·00854759007076·Waist/Leg Strap Extender

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·00854759007038·Tip Tension Guide

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·00854759007069·Leg Strap, reusable

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·00854759007014·RigiScan Monitor

    RigiScan Plus

    FDA UDI
    GOTOP MEDICAL INC·00854759007007·RigiScan Plus System

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·00854759007045·Loop Covers, Dis, 12pk

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·00854759007021·Base Tension Guide

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·00854759007083·Communication Cable

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·10854759007042·Disposable Loop Covers, 1 pr.

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·00854759007106·Event Marker Switch, RigiScan

    RigiScan

    FDA UDI
    GOTOP MEDICAL INC·10854759007059·Leg Strap, Disposable

    Atlantico Systems, Ltd.

    Authorized representative
    🇮🇪 Ireland·10 Manufacturers·165 Devices

    Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·March 3, 2021

    Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code JAK·August 18, 2021

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code JAK·March 7, 2022