7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CALCIUM, CATALOGUE NUMBER140-20
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SINGLE AND DUAL BAND DIPSTICK HCG TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2014
ATLAS II PLUS HF CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2010
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·January 3, 2013
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