7 results
·
16ms
·
Sources: EU EUDAMED, US FDA
ACU-HALT
FDA 510(k)TECHNA SUN LENS
FDA 510(k)
FDA Class 1
·Ophthalmic
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VISISTAT SKIN STAPLER 35W
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GAG·June 12, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·February 11, 2013
PASSIVE PLUS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011
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