131 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Brainsway Deep TMS System
FDA 510(k)
FDA Class 2
·Neurology
10PW - New Mexico Body Fluid
FDA UDI
Certified Safety Manufacturing, Inc.·00766588009575·10PW - New Mexico Body Fluid
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
FDA Enforcement
Class II
·Terminated·Encore Medical, Lp·September 6, 2017
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
FDA Recall
Terminated
·Product code HTO·August 4, 2017
HOFFMANN II EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ORACAM
FDA 510(k)
FDA Class 1
·Dental
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·April 3, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 12, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·April 8, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·July 16, 2025
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·March 30, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·May 11, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·May 8, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·May 18, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·April 9, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code IZI·April 22, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·May 7, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·April 17, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·May 11, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·April 17, 2026