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

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    FIR HEAT THERAPHY SYSYEMS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SI ASCOPE

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

    DYNAMIC ECG SYSTEM MODEL TLC5000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2022

    CADD SOLIS VIP PUMPS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2022

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 14, 2013

    CAD II

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·September 23, 2014

    TRIMA ACCEL PLT, PLS, RBC FRENCH SET

    FDA Adverse Event
    Malfunction ·CARIDIANBCT·Product code LKN·May 18, 2011

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 1, 2015

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 21, 2022

    SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 4, 2019

    SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    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 Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025