8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SHUR-GRIP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PORTA GEO TI MODEL #2004
FDA 510(k)
FDA Class 2
·Dental
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TPRLC 133 MP TYPE1 PPS HO 12.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·July 14, 2021
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES·Product code LZG·June 13, 2014
EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD.·Product code MQR·January 8, 2013
SUPER POLIGRIP ORIGINAL DENTURE CREAM
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·November 8, 2010
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021