9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CROSS-CHECKS
FDA 510(k)
FDA Class 2
·General Hospital
Medegen Medical Products, LLC
FDA UDI
MEDEGEN MEDICAL PRODUCTS, LLC·00673844002853·Bag: Ac 25X35 2.0Ml Red Pr 200/Cs
Elite® Buccal Tubes Direct Bond
FDA UDI
Ortho Organizers, Inc.·00190707074517·Elite®.022 EDGE U7R MINI HK DB
QUANTA SYSTEM ETRNA GIOVINEZZA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELITech Clinical Systems CALCIUM ARSENAZO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·February 8, 2013
COBAS 6000 C501MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JFY·January 6, 2011
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·July 22, 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