15 results
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30ms
·
Sources: EU EUDAMED, US FDA
STYLET TRACHAEL TUBE
FDA 510(k)
FDA Class 1
·Anesthesiology
PYRAMESH® C Titanium Mesh
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000855338·MESH 905-133 PYRM 13MM X 30MM ROUND
Pyramesh® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978080642·MESH 905-133 PYRM 13MM X 30MM ROUND
FACTOR II DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
DURACATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 15, 2022
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2014
TENDRIL DX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·November 22, 2010
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·June 27, 2020
BD SYRINGE 20ML 18G 1-1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·September 9, 2019
SYRINGE 20ML 18G 1-1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·October 30, 2019
SYRINGE 20ML 18G 1-1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·October 31, 2019
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024