7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN.
FDA 510(k)
FDA Class 1
·Anesthesiology
URIHESIVE SYSTEM - IMPROVED
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·November 24, 2010
SYSTEM 7 SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·January 30, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 4, 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