23 results
·
83ms
·
Sources: EU EUDAMED, US FDA
TRI-TECH MEDICAL, INC.
FDA registration
TRI-TECH MEDICAL, INC.·6 products·🇺🇸 United States
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·December 9, 2022
EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
FDA Recall
Terminated
·Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario·Product code GWF·January 2, 2015
EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.
FDA Recall
Terminated
·Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario·Product code GWE·January 2, 2015
ANGIOTECH
FDA Adverse Event
Malfunction
·MEDICAL DEVICE TECHNOLOGIES·Product code KNW·July 10, 2007
VISIONAIRE
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·November 29, 2017
CARDIOSAVE HYBRID, TYPE I PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·June 26, 2023
SENSAR IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·July 30, 2024
COULTER® ACT DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·November 2, 2012
DA VINCI SP
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·June 8, 2023
RELAY PRO THORACIC STENT-GRAFT SYSTEM
FDA Adverse Event
Malfunction
·BOLTON MEDICAL, INC.·Product code MIH·June 5, 2023
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA·Product code OUT·February 5, 2019
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·April 9, 2022
XMTR MMT-7811NA GST3C LOCKOUT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZP·December 28, 2023
MEDISYSTEMS READY SET
FDA Adverse Event
Other
·MEDISYSTEMS CORP.·Product code FJK·August 18, 1999
630G INSULIN PUMP MMT-1715K 630G BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·September 20, 2022
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·August 3, 2023
CARELINK CONNECT APP IOS
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·January 19, 2024
GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·August 18, 2023
GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·December 23, 2024