10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198635·AK3 Ultra Insert Trial Size 3, 18mm
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973108078·TRIAL 90-SRK-192318 POLY-MPCS 3X18 LEFT
CLEARPATH 24
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
QUARTET
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC, CRMD·Product code DTS·January 11, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 27, 2013
ULTRAFLEX DUO HIGH FLUID CART
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·August 28, 2017