7 results
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26ms
·
Sources: EU EUDAMED, US FDA
TECA NCS ELECTRODE SYSTEM 2000
FDA 510(k)
FDA Class 2
·Neurology
Cortina Lumbar Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
MERCURY SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN DEPUY SLEEVE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·February 21, 2013
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC·Product code GKZ·January 27, 2011
RUBY COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·July 31, 2014
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