8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AKRO-SIL FOLEY KIT 30CC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
C350 POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
Alere Afinion HbA1c and ACR on Afinion 2 analyzer
FDA 510(k)
FDA Class 2
·Hematology
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 24, 2014
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·May 13, 2015
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 28, 2010
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