7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACE/KYLE CAPTURED HIP SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
CMI IMPLANT IS SYSTEM
FDA 510(k)
FDA Class 2
·Dental
POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
PROLENE POLYPROPYLENE SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAW·May 15, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVY·October 31, 2012
CAPSURE Z NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2010
Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 30, 2014