12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROLLINS 7 OXYGEN MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
ArgenZ HT+ 98x20 ML C2B
FDA UDI
ARGEN CORPORATION, THE·D818130379·Dental porcelain/ceramic restoration kit
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450356852·
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 15, 2025
TELIO CS INLAY & TELIO CS ONLAY
FDA 510(k)
FDA Class 2
·Dental
APLAB, MODEL 801D0030
FDA 510(k)
FDA Class 2
·Anesthesiology
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·February 18, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·May 24, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 30, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011
95 DEG DCS® PLATE 8 HOLES/146MM
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code KTT·March 30, 2017
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013