10 results
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18ms
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Sources: EU EUDAMED, US FDA
ARCHIVEMANAGER
FDA 510(k)
FDA Class 1
·Radiology
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9505131·SICvantage Fixation Screw, short
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·04260516877282·SICvantage Fixation Screw, short
MDA B.30
FDA 510(k)
FDA Class 2
·Hematology
Imed Technology Intravascular Administration Set, Imed Technology Extension Set
FDA 510(k)
FDA Class 2
·General Hospital
ARTICULEZE M HEAD 36MM +5 K980513
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 14, 2016
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·February 8, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·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