9 results
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17ms
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Sources: EU EUDAMED, US FDA
N-ASSAY TIA FIBRINOGEN TEST KIT
FDA 510(k)
FDA Class 2
·Hematology
ROTO REST; TRAUMA AND INTENSIVE CARE BED
FDA 510(k)
FDA Class 2
·Physical Medicine
ENCORE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIBERTY POSTERIOR SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWQ·February 11, 2010
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code DTB·February 15, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LZG·July 29, 2014
APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code JDQ·July 7, 2015
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