8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
LD2000 SERIES
FDA 510(k)
FDA Class 2
·Radiology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665587879·MIS Cannulated Screw M, Ø10.5 x 65mm, Ø6.0mm Rod
MODIFICATION TO: SAVI APPLICATOR KIT
FDA 510(k)
FDA Class 2
·Radiology
PEAK NS033CF, PEAK NS017CF
FDA 510(k)
FDA Class 2
·Dental
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 25, 2014
CWS 400 CLOSED WOUND SUCTION KIT
FDA Adverse Event
Injury
·PRODUCTOS PARA EL CUIDADO DE LA SALUD·Product code GCY·February 21, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·February 7, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024