BEUDAMED
    47 results · 20ms · 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 ×

    Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CHP·January 13, 2016

    IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various hormonal sexual disorders

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CHP·January 13, 2016

    IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CHP·January 13, 2016

    Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension VistaSystem. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CHP·January 13, 2016

    Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Usa, Inc Dallas Distribution·Product code HBE·May 13, 2016

    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.

    FDA Recall
    Terminated ·TEM Systems Inc·Product code JPA·September 13, 2016

    Philips Healthcare System X-ray Tomography Computed :

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code JAK·March 15, 2016

    Philips Healthcare System X-ray Tomography Computed :

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code JAK·March 15, 2016

    MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LNH·April 13, 2016

    Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CHH·April 13, 2016

    Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code IFP·June 13, 2016

    MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK & APA

    FDA Recall
    Terminated ·Datascope Corporation·Product code DSP·May 13, 2016

    Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·April 13, 2016

    Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·April 13, 2016

    Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·April 13, 2016

    The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

    FDA Recall
    Terminated ·PMBS, LLC·Product code KCT·January 13, 2016

    Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·March 9, 2016

    Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KHP·April 13, 2016

    LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and management of conditions involving an excess or deficiency of estradiol. The test has to be performed on the LIAISON Analyzer Family.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code CHP·July 13, 2016

    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·April 13, 2016