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    VADER® Pedicle System and VADER®one Pedicle System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    devemed

    FDA UDI
    devemed GmbH·04061644032815·dev-aspir 1 | Basic suc. tube | 16.0cm without ...

    Burr

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113066·ALGERBRUSH II (OPHTHALMIC CORNEAL BURR)

    Tecomet

    FDA UDI
    TECOMET INC.·00841435121386·ELEVATOR DISSECTOR

    Reicodent

    FDA UDI
    devemed GmbH·04061644061525·REIC-aspir 1 | Basic suc. tube | 16.0cm without...

    Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh

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

    K.E.P. CONNECTOR AND CLIP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ANN PH NAIL RT 10X220MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·January 26, 2026

    ANN BLUNT TIP SCREW 4X40MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·January 26, 2026

    QUANTUM MAVERICK MR BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·November 19, 2008

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    DIMENSION VISTA 500

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code LTJ·July 23, 2013

    TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy.

    FDA Recall
    Terminated ·TomoTherapy Incorporated·Product code IYE·February 22, 2008

    TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717 The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.

    FDA Recall
    Terminated ·Accuray Incorporated·Product code MUJ·July 7, 2011

    TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. TomoTherapy HI-ART Systems is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital health tissue. The HI-Art system's planning station or operator station is intended to be used by the physician/oncologists to prescribe a radiation therapy plan for a particular patient,. The HI-ART System then calculates the treatment plan which the physician reviews and approves. The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage (MVCT) scan (a CT using the on board linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The TomoImage (MVCT) image is not for diagnostic use. When patient positioning is complete, the HI-ART System i sthen intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern.

    FDA Recall
    Terminated ·TomoTherapy Incorporated·Product code IYE·October 14, 2008

    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists

    FDA Recall
    Terminated ·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·May 30, 2011

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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