7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RevealAI-Lung
FDA 510(k)
FDA Class 2
·Radiology
Anchorage 2 CP System
FDA 510(k)
FDA Class 2
·Orthopedic
Cavetto [MAX] Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 14, 2014
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
POPULAR PLASTICS·Product code IKX·September 16, 2011
PROLONG CATHETER
FDA Adverse Event
Injury
·LIFE-TECH, INC.·Product code CAZ·June 21, 2013
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
FDA Enforcement
Class I
·Terminated·Synthes, Inc.·August 27, 2014