7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Surgical Face Masks (Ear Loops And Tie-On)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONE-TROL HEMOGLOBIN A1C CONTROL SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IQ NASAL MASK, MODEL 50160 REV. D
FDA 510(k)
FDA Class 2
·Anesthesiology
MAVERICK OVER-THE-WIRE PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·November 5, 2008
LTV
FDA Adverse Event
Injury
·CAREFUSION 203, INC·Product code CBK·August 17, 2011
NEXGEN CR-FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·July 9, 2013
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