309 results
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57ms
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Sources: EU EUDAMED, US FDA
GRAND MEDICAL, INC.
FDA registration
GRAND MEDICAL, INC.·2 products·🇺🇸 United States
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·LIVANOVA USA, INC.·Product code LYJ·September 23, 2022
PULSE GEN MODEL 106
FDA Adverse Event
Injury
·LIVANOVA USA, INC.·Product code LYJ·November 24, 2025
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·HOUSTON·Product code LYJ·October 15, 2025
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
FDA Enforcement
Class I
·Terminated·Nephros Inc·December 25, 2013
1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
FDA Enforcement
Class I
·Terminated·Nephros Inc·December 25, 2013
TMJ IMPLANT'S INC. FOSSA EMINENCE
FDA Adverse Event
Injury
·TMJ IMPLANTS, INC.·Product code LZD·November 5, 2002
PULSE GEN MODEL 1000
FDA Adverse Event
Injury
·LIVANOVA USA, INC.·Product code LYJ·December 2, 2022
PULSE GEN MODEL 1000
FDA Adverse Event
Injury
·CYBERONICS - HOUSTON·Product code LYJ·October 22, 2024
PULSE GEN MODEL 1000
FDA Adverse Event
Injury
·LIVANOVA USA, INC.·Product code LYJ·January 15, 2025
PULSE GEN MODEL 1000
FDA Adverse Event
Injury
·CYBERONICS - HOUSTON·Product code LYJ·November 1, 2023
PULSE GEN MODEL UNK
FDA Adverse Event
Death
·LIVANOVA USA, INC.·Product code LYJ·January 29, 2024
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·CYBERONICS - HOUSTON·Product code LYJ·October 6, 2023
PULSE GEN MODEL 106
FDA Adverse Event
Death
·CYBERONICS - HOUSTON·Product code LYJ·November 1, 2022
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·CYBERONICS - HOUSTON·Product code LYJ·November 12, 2024
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·LIVANOVA USA, INC.·Product code LYJ·October 3, 2022
HEMOLUNG RAS
FDA Adverse Event
Injury
·ALUNG TECHNOLOGIES, INC.·Product code QOH·January 18, 2023
PULSE GEN MODEL 106
FDA Adverse Event
Malfunction
·CYBERONICS - HOUSTON·Product code LYJ·September 6, 2023
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·July 14, 2025
PULSE GEN MODEL 106
FDA Adverse Event
Injury
·LIVANOVA USA, INC.·Product code LYJ·August 18, 2022