7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CATH-CARE TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEMOCUE WBC SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
Fresenius Liberty Select Cycler
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWERED WHEELCHAIR
FDA Adverse Event
INVACARE SUZHOU·Product code ITI·April 24, 2014
HUDSON NEONATAL CIRCUIT, DUAL HTD LIMB, 60 IN
FDA Adverse Event
Malfunction
·TELEFLEX·Product code BZO·September 26, 2012
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·May 13, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024