BEUDAMED
    60 results · 14ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    Invacare 2G Tarsys Seating System, Model 2GR.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·December 15, 2003

    Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZI·April 3, 2014

    DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code JDI·May 7, 2021

    Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZI·January 12, 2018

    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

    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

    AxSYM Myoglobin Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System; list 3E43-20

    FDA Recall
    Terminated ·Abbott Laboratories·Product code DDR·January 19, 2009

    Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic

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

    Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DDR·April 3, 2006

    AxSYM Myoglobin Reagent Pack; list 03E43; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code DDR·April 23, 2007

    Access Immunoassay Systems CORTISOL, Part Number: 33600

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGR·February 17, 2010

    The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGR·September 18, 2018

    Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DDR·April 3, 2006

    Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGR·July 20, 2009

    IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code CGR·September 19, 2014