8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCI-PHARM DFV VARNISH
FDA 510(k)
FDA Class 2
·Dental
SYNCHRON CREATINE KINASE REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code CGS·June 17, 2011
FORTIFY
FDA 510(k)
FDA Class 2
·Dental
ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TOTAL ASR FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 28, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·February 9, 2011
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·MERZ NORTH AMERICA, INC.·Product code LMH·July 11, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024