10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TEMPERATURE CONTROLLER MODEL 17000
FDA 510(k)
FDA Class 2
·Anesthesiology
TEMP. CROWN ACRYLIC RESIN
FDA 510(k)
FDA Class 2
·Dental
World Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
HUMAPEN UNKNOWN DEVICE
FDA Adverse Event
Injury
·ELI LILLY AND COMPANY·Product code NSC·April 30, 2014
ENDURANT II STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·October 10, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 12, 2007
COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE STD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·November 2, 2017
E1 44-36 STD HMRL BRNG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·November 2, 2017
COMPREHENSIVE REVERSE SHOULDER SYSTEM
FDA Adverse Event
Injury
·BIOMET·Product code KWS·September 20, 2017
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019