BEUDAMED
    146 results · 11ms · Sources: EU EUDAMED, US FDA

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    Straumann Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W

    FDA Recall
    Terminated ·Straumann Manufacturing, Inc.·Product code NQA·March 23, 2018

    Straumann Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099

    FDA Recall
    Terminated ·Straumann Manufacturing, Inc.·Product code NQA·March 23, 2018

    Straumann Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W

    FDA Recall
    Terminated ·Straumann Manufacturing, Inc.·Product code NQA·March 23, 2018

    Straumann Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113

    FDA Recall
    Terminated ·Straumann Manufacturing, Inc.·Product code NQA·March 23, 2018

    Straumann Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W

    FDA Recall
    Terminated ·Straumann Manufacturing, Inc.·Product code NQA·March 23, 2018

    Straumann Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115

    FDA Recall
    Terminated ·Straumann Manufacturing, Inc.·Product code NQA·March 23, 2018

    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

    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

    FDA Enforcement
    Class II ·Terminated·Abaxis Inc·June 24, 2020

    Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103

    FDA Recall
    Terminated ·Perkinelmer Life Sciences, Inc.·Product code DHN·July 21, 2003

    Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    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

    RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.

    FDA Recall
    Terminated ·Immuno Concepts Inc·Product code LLL·November 25, 2008

    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

    ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.

    FDA Recall
    Terminated ·Immuno Concepts Inc·Product code DHN·December 4, 2008

    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