8 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT
FDA 510(k)
FDA Class 2
·Dental
SpiritMB
FDA UDI
ORMCO CORPORATION·00889989007404·ID P - Twin - Upper-Universal Bicuspid - Orange
MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS
FDA 510(k)
FDA Class 2
·Radiology
Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
FDA 510(k)
FDA Class 2
·General Hospital
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·February 8, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 6, 2011
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·July 11, 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