8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VASCULAR ACCESS PORT CONTINUOUS INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
PLATELET-CHEX PLUS
FDA 510(k)
FDA Class 2
·Hematology
Arthrex SwiveLock Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·June 11, 2014
OPTICAL MODULE II
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code ISN·November 4, 2010
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·December 21, 2012
BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·April 22, 2020
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020