7 results
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18ms
·
Sources: EU EUDAMED, US FDA
CURITY PEAKOMETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
cobas m 511 integrated hematology analyzer
FDA 510(k)
FDA Class 2
·Hematology
REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·April 24, 2014
VASOVIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 29, 2012
ALARIS® PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION SD·Product code FRN·May 14, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024