175 results
·
65ms
·
Sources: EU EUDAMED, US FDA
HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·January 29, 2021
DIMORA SILICONE FOAM DRESSING WITH BORDER
FDA Adverse Event
Injury
·WINNER MEDICAL CO.,LTD.·Product code NAD·March 24, 2025
DIMORA SILICONE FOAM DRESSING WITH BORDER
FDA Adverse Event
Injury
·WINNER MEDICAL CO.,LTD.·Product code NAD·March 24, 2025
Silicone adhesive tapes
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Pharmaplast·32 devices
DIMORA SILICONE FOAM DRESSING WITH BORDER
FDA Adverse Event
Injury
·WINNER MEDICAL CO., LTD.·Product code FRO·February 19, 2025
DIMORA SILICONE FOAM DRESSING WITH BORDER
FDA Adverse Event
Injury
·WINNER MEDICAL CO., LTD.·Product code FRO·February 19, 2025
DermaPro Waterproof Silicone Tape, SNS57232
FDA Enforcement
Class II
·Terminated·Safe N Simple, LLC·June 20, 2018
HEARTMATE 3 VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·January 24, 2018
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·June 21, 2019
ELECTRODE COVER PATCHES
FDA Adverse Event
Injury
·EBI, LLC.·Product code LOF·March 16, 2022
HUBLESS SILICONE FLAT DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·April 23, 2018
BD ANGIOCATH PLUS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·November 27, 2017
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 3, 2019
ZIO XT
FDA Adverse Event
Injury
·IRHYTHM TECHNOLOGIES, INC.·Product code DSH·April 9, 2026
WALGREENS
FDA Adverse Event
Injury
·PREMIER BRANDS OF AMERICA INC.·Product code FMP·March 20, 2024
DermaPro Waterproof Silicone Tape, SNS57232
FDA Recall
Terminated
·Safe N Simple, LLC·Product code KGX·December 14, 2017
THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·February 8, 2011
SAFESTEP HUBER NEEDLE SET 20G X 1 IN
FDA Adverse Event
Injury
·BARD ACCESS SYSTEMS·Product code FPA·February 19, 2020
SIZE 5 ACCOLADE II 127 DEG
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·March 20, 2017
EASYPUMP 2
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code MEB·April 18, 2024