8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
FDA 510(k)
FDA Class 2
·Immunology
RAYLOR(TM) DRILL STOP
FDA 510(k)
FDA Class 2
·Neurology
D-Actor 200 Vibration Massage System
FDA 510(k)
FDA Class 1
·Physical Medicine
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·November 21, 2017
SMALL BATTERY DRIVE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·February 22, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 1, 2014
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