9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General Hospital
SAMWON INNOTECH CO., LTD.
FDA registration
SAMWON INNOTECH CO., LTD.·3 products·🇰🇷 South Korea
REPICCI LOCKED KEEL TIBIAL BEARING
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 19, 2025
CUSTOM PAK
FDA Adverse Event
Malfunction
·ALCON - HOUSTON·Product code KYG·April 3, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC·Product code KWP·May 8, 2008
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 5, 2011
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024