7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
VAPLOK
FDA 510(k)
FDA Class 2
·Anesthesiology
C4 ANTIGEN ANTIBODY CONTROL
FDA 510(k)
FDA Class 2
·Immunology
FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER
FDA 510(k)
FDA Class 2
·General Hospital
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·June 10, 2014
BONE PLATE, MP, 6 HOLE, CURVED, BAR LENGTH 14.8MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·October 7, 2010
OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·November 8, 2012
DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
FDA Enforcement
Class II
·Terminated·Carestream Health, Inc.·January 29, 2014