309 results · 57ms · Sources: EU EUDAMED, US FDA

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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