10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XENON CIRCUIT
FDA 510(k)
FDA Class 2
·Radiology
Arx
FDA UDI
Life Spine, Inc.·00190837075361·Polyaxial Non-Cannulated Screw, 9.5x35mm
Arx
FDA UDI
Life Spine, Inc.·00190837126049·
Insufflator 50L FM134
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
T-PIN
FDA 510(k)
FDA Class 2
·Orthopedic
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MPRI·Product code OJX·February 9, 2013
TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·January 5, 2011
BONE SPREADER 12 MM BEAK WIDTH
FDA Adverse Event
Malfunction
·SYNTHES SALZBURG·Product code HWN·July 23, 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
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017