8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XLR8 Abdominal Wound Dressing Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Oticon A/S·05707131331663·OPN 3, KIT 10 NFM 85 C001
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
P & F POWER WHEELCHAIR, MODEL HC-500SB
FDA 510(k)
FDA Class 2
·Physical Medicine
TALOS SR
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·October 17, 2014
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 11, 2013
GE OEC 7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 25, 2008
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024