9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY
FDA 510(k)
FDA Class 2
·Orthopedic
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295240013·P.F.C. SIGMA FLUTED FEMORAL STEM 18mm x 175mm 7...
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158216013·SCISSOR FOMON CURVED 5 1/8"
MAGIS1;MAGIS2
FDA 510(k)
FDA Class 2
·Radiology
Dentium CAD/CAM Abutments
FDA 510(k)
FDA Class 2
·Dental
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·January 18, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 28, 2014
INVISALIGN SYSTEM
FDA Adverse Event
Other
·ALIGN TECHNOLOGY, INC.·Product code NXC·January 11, 2011
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