BEUDAMED
    152 results · 13ms · Sources: EU EUDAMED, US FDA

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    SurFlo IV Catheter

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·May 10, 2017

    8F ZUMA 2 SR 4.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40SH

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    8F ZUMA 2 SR 3.5 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35SH

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    8F ZUMA 2 SR 5.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50SH

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    8F ZUMA 2 SR 4.0 100CM CATHETER Z28SR40 Z2 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    8F ZUMA 2 SR 3.0 100CM CATHETER Z28SR30 Z2 8F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR30

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    8F ZUMA 2 SR 5.0 100CM CATHETER Z28SR50 Z2 8F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    8F ZUMA 2 SR 3.5 100CM CATHETER Z28SR35 Z2 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DDR·September 27, 2007

    Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20

    FDA Recall
    Terminated ·Nellcor Puritan Bennett·Product code BSR·July 12, 2006

    Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.

    FDA Recall
    Terminated ·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008

    Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BSR·August 24, 2015

    Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack.

    FDA Recall
    Terminated ·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008

    Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code DDR·November 11, 2015

    ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code DDR·March 5, 2018

    ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code DDR·October 17, 2005

    Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code DDR·August 8, 2016

    The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DDR·July 2, 2019

    Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DER·May 16, 2018

    Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamunting, Perak, Malaysia. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BSR·December 2, 2011