10 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LESE STENTS SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arx
FDA UDI
Life Spine, Inc.·00190837126025·
Arx
FDA UDI
Life Spine, Inc.·00190837075484·Polyaxial Non-Cannulated Screw, 9.5x 25mm
8X-10-XXXX Camera System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BABY SNOOPY WATER FILLED TEETHER, MODEL 95367
FDA 510(k)
FDA Class 2
·Dental
PORTEX ENDOTRACHEAL TUBES SACETT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC·Product code BTR·February 26, 2020
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 15, 2014
ATTAIN OTW
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·February 9, 2013
SIGMA 300 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·January 7, 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