BEUDAMED
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    S4 SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902164057·TAP 9112551 TCD ADJ 20MM

    PENCAN®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025

    LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·May 14, 2013

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    KENSTONE METAL·Product code IKX·September 24, 2014

    ELECTRIC MED/SURG BED

    FDA Adverse Event
    Malfunction ·FLEXTRONICS EMS CANADA·Product code FNL·May 25, 2011

    ABSOLUTE PRO LL PERIPHERAL SELF EXPANDING STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code FGE·February 4, 2011

    PENCAN®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·March 3, 2025

    SOMATOM go.Up (Model #11061610) 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