9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DELTA XTEND(TM) Reverse Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
Costco
FDA UDI
Bernafon AG·05711584089576·CAPTO 1 MNR T, 2.4G NFM DPB MAC/MSIL COSTC
UNIVERSAL IRRIGATION SOLUTION HYBRID
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MILTEX MEMBRANE TACK KIT
FDA 510(k)
FDA Class 2
·Dental
NOVASURE
FDA Adverse Event
Malfunction
·HOLOGIC INC·Product code MNB·October 16, 2014
PELVITEX POLYPROPYLENE MESH
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·May 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 25, 2011
DOUBLE INSERT F/EXTRACT 2+2.4 T6+T8 F/DR
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HXX·January 11, 2017
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021