354 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
48" Lead Wires, Replacement Part Number: 1067724-4
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
20" Lead Wires, Replacement Part Number: 1067724-2
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
EXOGEN Ultrasound Coupling Gel
FDA Recall
Terminated
·Bioventus, LLC·Product code LOF·December 17, 2020
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
FDA Recall
Open, Classified
·Philips North America·Product code LNI·July 15, 2021
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation Instructions for Use
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code OWD·March 15, 2016
Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems Cat No. 02789602/SMN 1031 7708 (100 test) Cat No. 02790309/SMN 10317709 (500 test)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code MMI·May 2, 2016
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JGJ·December 8, 2021