9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
FDA 510(k)
FDA Class 1
·Anesthesiology
SONOPAK/QS, SONOPAK
FDA 510(k)
FDA Class 1
·Dental
MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28
FDA 510(k)
FDA Class 2
·Radiology
RUSCH GREENSPEC FIBER OPTIC HANDLE, MEDIUM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CCW·June 12, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 11, 2013
QUICKFLEX XL LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011
VIDAS ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·January 21, 2021
VIDAS® ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·September 16, 2021
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024