8 results
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19ms
·
Sources: EU EUDAMED, US FDA
CARBON FIBER PALLET
FDA 510(k)
FDA Class 1
·Radiology
SUN SIGHT SUNGLASSES/SUN SIGHT READING GLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
DEVILBISS MODEL 7352 SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
SHELL POROUS WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·May 26, 2017
HUDSON ADULT CONVENTIONAL BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAI·January 23, 2013
HOMEPUMP ECLIPSE
FDA Adverse Event
Malfunction
·I-FLOW CORP.·Product code MEB·December 13, 2010
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·July 15, 2014
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 4, 2013