8 results
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27ms
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Sources: EU EUDAMED, US FDA
SUBJECTIVE REFRACTOR, MOSEL SR-111
FDA 510(k)
FDA Class 1
·Ophthalmic
Cortina Lumbar Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
MERCURY SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNICEL® DXC 600 PRO SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·April 25, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 29, 2007
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·September 28, 2012
NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662, STERILE, Rx ONLY ---- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 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