9 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.
FDA Recall
Terminated
·Qrs Diagnostic·Product code LOS·February 16, 2012
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
FDA Recall
Terminated
·Boddingtons Plastics Ltd Wheelbarrow Park Estate Pattenden Lane Tonbridge United Kingdom·Product code FED·March 11, 2020
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
FDA Enforcement
Class II
·Terminated·Boddingtons Plastics Ltd·April 22, 2020
Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy
FDA Recall
Terminated
·ela Medical Llc·Product code NIK·June 7, 2010
Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.
FDA Recall
Terminated
·Azer Scientific, Inc.·Product code MRV·August 24, 2016
Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.
FDA Recall
Terminated
·Azer Scientific, Inc.·Product code MRV·August 24, 2016
Bone Marrow Biopsy Tray Catalog Number: 8917R1
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code PRV·February 22, 2022
S/P Orange 50g Glucose Tolerance Beverage, 10 oz glass bottles, 12 bottles/case, labeled in part ***Cardinal Health McGaw Park, IL 60085-6787 USA*** For prescription use only. Product is used in support of diagnostics testing for hyperglycemia and hypoglycemia.
FDA Recall
Terminated
·Nerl Diagnostics LLC·Product code MRV·April 23, 2008
ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1L75-25. The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver and kidney transplant patients receiving cyclosporine therapy.
FDA Recall
Terminated
·Abbott Laboratories·Product code MKW·October 7, 2011