7 results
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22ms
·
Sources: EU EUDAMED, US FDA
GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA
FDA 510(k)
FDA Class 1
·Microbiology
MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT
FDA 510(k)ALPHA MASS STORAGE CARDULE 1895
FDA 510(k)
FDA Class 2
·Cardiovascular
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 10, 2014
TOTAL ABSCESSION DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·ANGIODYNAMICS, INC.·Product code DQY·October 5, 2010
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·December 10, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024