BEUDAMED
    186 results · 19ms · Sources: EU EUDAMED, US FDA

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    5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040 Yellow, 24 count containers; Made in USA for: Medline Industries; BEMIS label has Manufactured by Bemis Mtg. Co., Sheboygan Falls, WI.

    FDA Recall
    Terminated ·Bemis Health Care, Inc·Product code MMK·August 23, 2006

    VITROS XT3400 Chemistry System, Product code 6844458

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics·September 2, 2020

    VITROS XT7600 Integrated System, Product code 6844461

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics·September 2, 2020

    PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1

    FDA Enforcement
    Class II ·Terminated·Whirlpool Corporation·August 26, 2020

    FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·August 5, 2015

    PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1

    FDA Recall
    Terminated ·Whirlpool Corporation World Headquarters Benton·Product code NZJ·July 2, 2020

    Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF***QTY 1 BioScrew XtraLok ***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA***''.

    FDA Recall
    Terminated ·Linvatec Corp.·February 22, 2005

    Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF*** QTY 1***Hornet Disposable Inserter, BioStinger Implant***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33733 USA***''.

    FDA Recall
    Terminated ·Linvatec Corp.·Product code JDI·February 22, 2005

    Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6120A QTY 1 BIO-ANCHOR, PRE-LOADED 3.5mm x 10.5 mm ***STERILE ***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA.***''

    FDA Recall
    Terminated ·Linvatec Corp.·Product code JDI·February 22, 2005

    Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121 QTY 1 3.5mm Bio-Anchor with Disposable Driver***STERILE***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 33773 USA***''.

    FDA Recall
    Terminated ·Linvatec Corp.·Product code JDI·February 22, 2005

    MRP-7000, AIRIS Magnetic Resonance Imaging Systems

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code LNH·March 17, 2006

    Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121H QTY 1 3.5 x 10.5 mm Bio-Anchor with Disposable Driver, Preloaded with One #2 Herculine Suture***STERILE ***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 33773 USA***''.

    FDA Recall
    Terminated ·Linvatec Corp.·Product code JDI·February 22, 2005

    Bemis Two-Gallon Sharps Container, Models #102 020, #102 030, and #102 040. (The only difference between the models is in color. Model 102 040 is yellow, Model 102 020 is beige and Model 102 030 is red. )

    FDA Recall
    Terminated ·Product code MMK·February 25, 2004

    FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139

    FDA Recall
    Terminated ·Product code HWT·June 24, 2015

    BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne. Nicolet Biomedical, Inc.

    FDA Recall
    Terminated ·Nicolet Biomedical Div of Viasys Healthcare·Product code GWQ·July 17, 2007

    ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.

    FDA Recall
    Terminated ·Data Innovations, LLC·Product code JQP·August 15, 2014

    CryoPatch SG Pulmonary Hemi-Artery Patch

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·May 1, 2019

    CryoPatch SG Pulmonary Hemi-Artery, 1 graft

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·October 24, 2018

    CryoPatch SG Pulmonary Hemi-Artery Patch

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code DXZ·November 21, 2016

    Pulmonary Hemi-Artery SG Used in heart surgery

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·January 29, 2014