10 results
·
34ms
·
Sources: EU EUDAMED, US FDA
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
Cascadia™ Interbody System
FDA UDI
VB Spine LLC·10888857369771·Trial, Size 12x14x11 mm, 15°
Qitexio
FDA 510(k)
FDA Class 2
·General Hospital
DSS Sinusplasty Balloon Catheter
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 9, 2023
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 29, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
3.5MM LC-DCP® PLATE 6 HOLES/77MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·April 23, 2018
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
FDA Recall
Terminated
·Avanos Medical, Inc.·Product code PSG·March 16, 2020