9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Cellvizio 100 Series System with Confocal Miniprobes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FREESTYLE
FDA Adverse Event
Injury
·THERASENSE, INC.·Product code LFR·January 31, 2005
SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO:RADIUS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
36MM COCR MOD HD -3MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·October 21, 2014
CURLIN INFUSION IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·June 14, 2013
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 19, 2011
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016