7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURAFILL MICROFILL RESTORATIVE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
BW ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
FDA 510(k)
FDA Class 2
·General Hospital
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 22, 2007
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012
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