7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPECTRUM DISIGNS PECTORAL IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CLINICAL BLOOD GAS MIXTURES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EZ 502
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 7, 2014
NDEHP MACRO 30IN EXT
FDA Adverse Event
Malfunction
·HOSPIRA, LTD·Product code FPK·December 6, 2010
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 5, 2013
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024