295 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Clinical Chemistry Uric Acid; LN 7D76-20
FDA Recall
Terminated
·Abbott Laboratories Diagnostic Div·Product code CDO·March 18, 2004
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·March 28, 2013
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
FDA Recall
Completed
·Philips Ultrasound Inc·Product code IYN·July 22, 2021
Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code NPT·July 9, 2019
Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
SmartPath to dStream for 3.0T Model Number (REF): 782145
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code NPT·July 9, 2019
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code NPT·July 9, 2019
Ingenia 1.5T S Model Number (REF): 781347
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Achieva 3.0T TX for PET Model Number (REF): 781479
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code NPT·July 9, 2019