9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DISPOSABLE MANIFOLD
FDA 510(k)
FDA Class 2
·Cardiovascular
CANAL WALL PROSTHESIS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 10, 2014
CONCERTO CRT-D DR
FDA Adverse Event
MEDTRONIC MED REL, INC.·Product code NIK·October 12, 2010
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code DTB·December 10, 2012
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020