8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
AIRCARE OXYGEN GENERATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
NA
FDA UDI
aap Implantate AG·04042409361050·Depth gauge for screws ø4.5-6.5, up to L 100mm
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
VITROS XT Chemistry Products GLU-Ca Slides
FDA 510(k)
FDA Class 2
·Clinical Chemistry
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 5, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 31, 2007
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics, Inc.·March 12, 2025