7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HUMAN IGD IMMUNOLOGICAL NL TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
L-25 ABSORBABLE SURIGCAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Astroglide Sensual Strawberry Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 22, 2010
2124215-2012-17113
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code LWS·January 14, 2013
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·July 3, 2014
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015