BEUDAMED
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    INTEGRADWEB BY DYNAMIC IMAGING, INC.

    FDA 510(k)
    FDA Class 2 ·Radiology

    HITACHI HI VISION 6500

    FDA Adverse Event
    Malfunction ·HITACHI MEDICAL CORP.·Product code KPS·March 5, 2004

    NAVISTAR® THERMOCOOL®

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·August 26, 2014

    EVEREST SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·K2M, INC.·Product code NKB·November 2, 2017

    ION

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·December 9, 2022

    UNKNOWN

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·March 17, 2026

    EVEREST® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·K2M, INC.·Product code NKB·February 13, 2019

    EVEREST® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·K2M, INC.·Product code NKB·February 8, 2019

    DEFORMITY, UNIPLANAR SCREW; SIZE 6.5X45 MM

    FDA Adverse Event
    Injury ·K2M, INC.·Product code NKB·September 12, 2019

    syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images.

    FDA Recall
    Terminated ·Siemens Medical Solutions, USA, Inc·Product code LLZ·March 24, 2011

    CASPIAN® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION·Product code KWP·March 13, 2018

    DENALI SPINAL SYSTEM

    FDA Adverse Event
    Injury ·K2M INC.·Product code NKB·June 3, 2019

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·November 14, 2025

    Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code IYN·October 2, 2007

    DA VINCI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·September 23, 2021

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·May 8, 2024

    syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation.

    FDA Recall
    Terminated ·Siemens Medical Solutions, USA, Inc·Product code LLZ·May 10, 2011

    DAVINCI XI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·April 8, 2022

    UNK - SCREWS: TRAUMA

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HWC·June 8, 2023

    Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems contain the PURE software option.) Excite MR system is indicated for use as a diagnostic imaging device to produce images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code LNH·October 6, 2009