10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROWICK
FDA 510(k)
FDA Unclassified
·Unknown
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 5, 2013
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0830090·Persuader, Rod Reduction, Kerrison Type
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130070·Rocker, One Piece
BELLEGLASS HP ENAMEL 2
FDA 510(k)
FDA Class 2
·Dental
GALAXY
FDA 510(k)
FDA Class 2
·Dental
COVEREDGE 32
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 22, 2024
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
MARINR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DRF·May 10, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·July 28, 2008