7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ICONACY I-HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
FDA 510(k)
FDA Class 2
·General Hospital
CORRIDOR4DM V2010 MODEL: V2010
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·October 1, 2014
RAPIDPOINT 405
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CHL·May 13, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 16, 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