7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACID PHOSPHATASE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INTEL HEALTH GUIDE, MODEL: PHS6000
FDA 510(k)
FDA Class 2
·Cardiovascular
Prime Acetabular Cup System
FDA 510(k)
FDA Class 2
·Orthopedic
FINELINE II EZ STEROX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DTB·June 18, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025