BEUDAMED
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    TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues.

    FDA Recall
    Terminated ·TomoTherapy Incorporated·Product code MUJ·January 26, 2011

    MRIdian Linac Radiation Therapy System, Model 20000.

    FDA Enforcement
    Class II ·Terminated·Viewray, Inc.·May 8, 2019

    Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·November 20, 2019

    Hi-Art System, H-0000-0003 Usage: 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 ·TomoTherapy Incorporated·Product code MUJ·December 1, 2009

    STA UNICALIBRATOR (ref. 00675)

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·January 1, 2020

    MRIdian Linac Radiation Therapy System, Model 20000.

    FDA Recall
    Terminated ·Viewray, Inc.·Product code IYE·March 18, 2019

    STA SYSTEM CONROL N + P (ref. 00678)

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·January 1, 2020

    SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.

    FDA Enforcement
    Class II ·Terminated·Vitrolife Inc·April 22, 2015

    AVID Medical QA Pack AV10654-10

    FDA Recall
    Terminated ·Avid Medical, Inc.·Product code LRO·July 3, 2017

    Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·August 9, 2019

    AVID Medical QA Pack AV10654-10

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·February 21, 2018

    STA SYSTEM CONROL N + P (ref. 00678)

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGN·November 18, 2019

    STA UNICALIBRATOR (ref. 00675)

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GIZ·November 18, 2019

    Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code LXH·October 16, 2009

    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LTW·June 14, 2013

    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·August 14, 2013

    SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.

    FDA Recall
    Terminated ·Vitrolife Inc·Product code KTO·December 22, 2014

    BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

    FDA Recall
    Terminated ·Brainlab AG Kapellenstrasse 12 Feldkirchen Germany·Product code IYE·July 16, 2013

    BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·September 4, 2013

    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

    FDA Recall
    Terminated ·Materialise USA LLC·Product code HRY·November 26, 2013