106 results · 56ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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