7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONE UP DISPOSABLE KERATOME HEAD
FDA 510(k)
FDA Class 1
·Ophthalmic
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981742·anteriors; shade A3.5 light; mould UM8
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·February 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 27, 2016