19 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016841·NeuroPack, 1 Large Bur Hole plate
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361010456·PedFuse Reset, SLD, 9.0mm x 55mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361010449·PedFuse Reset, SLD, 9.0mm x 50mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361010470·PedFuse Reset, SLD, 9.0mm x 65mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361010432·PedFuse Reset, SLD, 9.0mm x 45mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361010418·PedFuse Reset, SLD, 9.0mm x 35mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361010401·PedFuse Reset, SLD, 9.0mm x 30mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361010500·PedFuse Reset, SLD, 9.0mm x 80mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361010494·PedFuse Reset, SLD, 9.0mm x 75mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361010487·PedFuse Reset, SLD, 9.0mm x 70mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361010425·PedFuse Reset, SLD, 9.0mm x 40mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361010463·PedFuse Reset, SLD, 9.0mm x 60mm
EXTRICARE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFIED STRAIGHT FIRE LASER FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code MND·June 13, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 27, 2011
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·September 26, 2008
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·April 24, 2019