8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ND:YAG Laser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AGXO
FDA UDI
Oticon A/S·05707131342997·G200, MINIRITE 312 2.4G C091 AGXO
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
RAPIDSORB PLUS SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EFFECTA S
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code DXY·June 27, 2013
PLUM A+3 PUMP MEDNET WIRELESS
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·October 7, 2008
COULTER LH750
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·May 10, 2011
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