8 results
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19ms
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Sources: EU EUDAMED, US FDA
TEK-CHEK-2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Neodent Instrument Kits
FDA 510(k)
FDA Class 2
·General Hospital
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IKX·April 24, 2014
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 4, 2012
MAVERICK2 BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·July 28, 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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025