106 results
·
56ms
·
Sources: EU EUDAMED, US FDA
SMART DOSE IV SET
FDA Adverse Event
Malfunction
·RIVER MEDICAL, INC.·Product code FPA·May 16, 1996
SMART DOSE
FDA Adverse Event
Malfunction
·RIVER MEDICAL, INC.·Product code MEB·June 20, 1995
SMART DOSE II 100 ML & 100 M/HR IV SET
FDA Adverse Event
Malfunction
·RIVER MEDICAL, INC.·Product code MEB·April 24, 1995
SMART DOSE II. INFUSION CONTAINER
FDA Adverse Event
Malfunction
·RIVER MEDICAL, INC.·Product code MEB·October 2, 1995
SMART DOSE INFUSION DEVICE
FDA Adverse Event
Malfunction
·RIVER MEDICAL, INC.·Product code MEB·July 28, 1995
SMART DOSE INFUSION DEVICE
FDA Adverse Event
Malfunction
·RIVER MEDICAL, INC.·Product code MEB·July 28, 1995
SMART DOSE
FDA Adverse Event
Malfunction
·RIVER MEDICAL, INC.·Product code MEB·July 10, 1995
SMART DOSE ELASTOMERIC INFUSION PUMP
FDA Adverse Event
Malfunction
·RIVER MEDICAL, INC.·Product code MEB·July 11, 1995
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
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 11, 2021
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 23, 2020
CARDIOSAVE HYBRID, TYPE I PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·June 26, 2023
UNKNOWN
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·January 5, 2018
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 7, 2022
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 29, 2021
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 17, 2021
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 8, 2021
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 16, 2021
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 20, 2023