10 results
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18ms
·
Sources: EU EUDAMED, US FDA
LAMP DELIVERY SYS.-PHOTOCOAGULATION
FDA 510(k)
FDA Class 2
·Ophthalmic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517822055·Interlock II Trial, 13x17x14mm 20° Stop
VELLAmini 5% Sodium Fluoride Varnish Spearmint Box 35
FDA UDI
Preventech·D024772213·VELLAmini 5% Sodium Fluoride Varnish Spearmint ...
LEONE SPA
FDA UDI
LEONE SPA·08033707067214·LIGATURES MINI modules TRANSP MEDIUM
MECRON Cannulated Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
PERIMETRICS PERIOMETER
FDA 510(k)
FDA Class 1
·Dental
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·March 28, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 4, 2012
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 22, 2010
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.
FDA Enforcement
Class II
·Terminated·Battle Creek Equipment Co.·November 9, 2016