9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BURNETT TMJ APPLIANCE
FDA 510(k)
FDA Class 2
·Dental
GC Initial™
FDA UDI
Gc America Inc.·J0228702431·GC Initial™ MC Chroma Shade Translucent CST-D, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556703509·GC Initial™ MC Chroma Shade Translucent CST-D, 20g
SUTRALENE POLYPROPYLENE SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOSPA IS TLIF & DLIF Cages
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 12, 2014
PENUMBRA SYSTEM REPERFUSION CATHETER 4MAX
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·December 12, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·October 11, 2010
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