8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTO SUTURE SURGICLIP DISPOS. CLIP APPL
FDA 510(k)Vilex Tool
FDA UDI
VILEX IN TENNESSEE, INC.·00841731116680·Staple Drill Guide #12
Portrait GBS Assay
FDA 510(k)
FDA Class 1
·Microbiology
NOBELRONDO DENTAL CERAMIC - ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 14, 2014
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·November 22, 2012
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 22, 2010
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024