11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UTERINE INJECTOR 2MM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Legacy™ Healing Collar Concave Profile
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307133469·
Legacy™4 Healing Collar-Concave Profile
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307112273·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867358232·Low Profile Screw, Cortical,3.5x15mm,DRP
TRANS1 FACET SCREW
FDA 510(k)
FDA Unclassified
·Unknown
Admiral Xtreme
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 14, 2014
EPIC II CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 15, 2012
X-STOP IPD SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SPINE, LLC·Product code NQO·September 22, 2010
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing, LLC·November 20, 2019
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing, LLC·Product code DZE·August 9, 2019