10,000 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRESERVARIDGE PLUG
FDA Adverse Event
Injury
·COLLAGEN MATRIX, INC.·Product code NPM·November 10, 2023
PRESERVARIDGE PLUG
FDA Adverse Event
Injury
·COLLAGEN MATRIX, INC.·Product code NPM·November 10, 2023
PRESERVARIDGE PLUG
FDA Adverse Event
Injury
·COLLAGEN MATRIX, INC.·Product code NPM·November 10, 2023
PRESERVARIDGE PLUG
FDA Adverse Event
Injury
·COLLAGEN MATRIX, INC.·Product code LYC·November 10, 2023
PRESERVARIDGE PLUG
FDA Adverse Event
Injury
·COLLAGEN MATRIX, INC.·Product code NPM·November 10, 2023
BONE GRAFTING MATERIAL, SYNTHETIC
FDA Adverse Event
Injury
·SYNTHES USA·Product code LYC·July 19, 2017
BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.
FDA Enforcement
Class II
·Terminated·Kerr Corporation·November 28, 2012
BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.
FDA Recall
Terminated
·Kerr Corporation·Product code LYC·October 25, 2012
CERASORB
FDA Adverse Event
Injury
·ABBOTT/ SPINAL CONCEPTS·Product code LYC·December 23, 2016
ENDOBON XENOGRAFT GRANULES 0.5ML
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LYC·December 30, 2016
ENDOBON XENOGRAFT GRANULES .5ML,500-1000
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LYC·October 14, 2016
ENDOBON XENOGRAFT GRANULES
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LYC·November 21, 2016
TERUPLUG
FDA Adverse Event
Injury
·OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY·Product code LYC·August 27, 2015
15X20MM BIOMEND
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORP.·Product code LYC·February 10, 2012
HELIMEND ADV 30 X 40
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC·Product code LYC·February 23, 2012
BIOPLANT
FDA Adverse Event
Injury
·KERR CORPORATION·Product code LYC·January 16, 2009
BIOPLANT
FDA Adverse Event
Injury
·KERR CORPORATION·Product code LYC·January 16, 2009
ATRISORB-D FREEFLOW BIOABSORBABLE GTR
FDA Adverse Event
Injury
·TOLMAR INC.·Product code LYC·March 11, 2009
MIMIX 10 GRAMS
FDA Adverse Event
Other
·BIOMET MICROFIXATION·Product code LYC·February 12, 2009
0003 - 4060-2 KIT
FDA Adverse Event
Malfunction
·ZIMMER DENTAL INC.·Product code LYC·January 21, 2009