16 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ResCUBE Ligament Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
GORE TRI-LOBE BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
1823260-2015-04555
FDA Adverse Event
Malfunction
·November 16, 2015
1823260-2015-04428
FDA Adverse Event
Malfunction
·November 2, 2015
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
CURRENT PLUS DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
6000CMS IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 6, 2013
1823260-2015-03973
FDA Adverse Event
Malfunction
·August 14, 2015
1823260-2015-03950
FDA Adverse Event
Malfunction
·August 12, 2015
1823260-2015-03685
FDA Adverse Event
Malfunction
·June 19, 2015
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 14, 2025
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·September 10, 2015
1823260-2015-04499
FDA Adverse Event
Malfunction
·November 10, 2015
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 13, 2016
GORE® TRI-LOBE BALLOON CATHETER
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DQY·February 24, 2021