9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURACON X3 CS TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 24, 2021
TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
FDA 510(k)
FDA Class 2
·Radiology
ELECSYS PROBNP CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·April 22, 2013
AED PRO
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 15, 2011
MAXCEM
FDA Adverse Event
Malfunction
·KERR CORPORATION·Product code EMA·July 9, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 6, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024