8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DiaPlus
FDA 510(k)
FDA Class 2
·Dental
MICROFUSE PUTTY AND MICROFUSE ST MIS
FDA 510(k)
FDA Class 2
·Orthopedic
HIVOX BIOTEK INC.
FDA 510(k)
FDA Class 2
·Neurology
FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code OWN·March 5, 2025
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 6, 2008
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 18, 2013
THERMODILUTION VENOUS INFUSION PORT (VIP) FIVE LUMEN
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, LLC.·Product code DYG·July 2, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018