34 results
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50ms
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Sources: EU EUDAMED, US FDA
Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medical point-of-care device designed to warm blood and IV fluids.
FDA Recall
Terminated
·Enginivity LLC·Product code LGZ·March 23, 2009
PULSE GEN MODEL 1000-D
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·March 29, 2024
SYNERGY VERSITREL
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·March 30, 2016
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 11, 2018
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 20, 2019
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 2, 2018
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·May 8, 2018
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·November 10, 2025
PULSE GEN MODEL 106
FDA Adverse Event
Malfunction
·CYBERONICS - HOUSTON·Product code LYJ·September 19, 2023
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·CYBERONICS - HOUSTON·Product code LYJ·August 2, 2024
PULSE GEN MODEL 104
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·December 20, 2022
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·February 2, 2024
PULSE GEN MODEL 106
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·March 24, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025
PULSE GEN MODEL 106
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·October 28, 2025
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·November 12, 2018
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·August 11, 2025
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·February 27, 2024