7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Introcan Safety 2 IV Catheter 18-24 gauge
FDA 510(k)
FDA Class 2
·General Hospital
TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·March 7, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013