7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CombiDiagnost R90
FDA 510(k)
FDA Class 2
·Radiology
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CARRIAZO PENDULAR
FDA 510(k)
FDA Class 1
·Ophthalmic
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·November 6, 2014
THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·July 18, 2013
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024