12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pounce Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
inCoris ZI
FDA UDI
SIRONA Dental Systems GmbH·E27662318282·inCoris ZI meso F2 S 1 Piece
MILAGRO
FDA UDI
Medos International Sàrl·10886705022328·MILAGRO ADVANCE INTERFERENCE SCREW Absorbable -...
NATURALASE LP ND:YAG LASER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
KII FIOS FIRST ENTRY
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES CORP·Product code GCJ·August 25, 2015
TEXIUM
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FMF·March 19, 2026
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPRSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·November 11, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011
OUTLOOK ES
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FRN·July 15, 2013
CTF03, 5X100 KII FIOS Z-THR 6/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·September 25, 2015
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012