12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RELYX RMGIP
FDA 510(k)
FDA Class 2
·Dental
TELERADPRO
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
OBTAPE TRANSOBTURATOR SLING
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code OTN·May 8, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
OT ULTRA TEST STRIPS
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 13, 2011
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024