7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NON-SHIELDED SURGICAL TROCAR AND SLEEVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
2X2 SPONGES, NON-STERILE
FDA 510(k)
FDA Unclassified
·Unknown
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 15, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 22, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 7, 2014
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020