7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHORESOR II AUTO, MODEL PM800 MODIFICATION
FDA 510(k)
FDA Class 2
·Physical Medicine
SECONDARY CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMEDA PHOTOTHERAPY LAMP FOR NEWBORN
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 7 SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·January 30, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·November 24, 2010
SLING WITH MESH
FDA Adverse Event
Injury
·Product code OTN·July 10, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024