8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BreathID Hp Lab System
FDA 510(k)
FDA Class 1
·Microbiology
SCALP BD¿ ASEPTO CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 8, 2017
MULTILASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUIDEL MOLECULAR INFLUENZA A+B
FDA 510(k)
FDA Class 2
·Microbiology
MULTISPOT HIV-1/HIV-2 RAPID TEST KIT
FDA Adverse Event
BIO-RAD LABORATORIES·Product code MZF·October 9, 2014
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 17, 2013
RAPIDO ADVANCE
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code DYB·July 24, 2011
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017