354 results · 17ms · Sources: EU EUDAMED, US FDA

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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