7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InstaFill Graft Delivery System, SIGNIFY Bioactive
FDA 510(k)
FDA Class 2
·General Hospital
Posterior Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
REPHRESH VAGINAL GEL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 3, 2014
KEEPSAFE DELUXE NO POWER SWITCH
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·August 17, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 11, 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