8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPECTRUM DESIGNS SPECTRAGEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TSV BellaTek Express and BellaTek Flex Abutments
FDA 510(k)
FDA Class 2
·Dental
ACU007S
FDA 510(k)
FDA Class 2
·Radiology
NFORCE NITINOL HELICAL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·July 3, 2018
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·March 4, 2013
SECURA DR
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code LWS·August 8, 2014
ENTRUST AT
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·February 15, 2011
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