9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
P.F.C. SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295237945·P.F.C. SIGMA STABILIZED TIBIAL INSERT TRIAL SZ ...
C-STEM
FDA UDI
DEPUY INTERNATIONAL LTD·10603295237952·C-STEM Hi-Offset Trial Stem Size 5
Low Profile Balloon Feeding Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
2520274-2013-10104
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·February 11, 2013
STERLING BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·January 14, 2011
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 28, 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