9 results
·
29ms
·
Sources: EU EUDAMED, US FDA
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
FDA 510(k)
FDA Class 2
·Microbiology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311519060·
XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY
FDA 510(k)
FDA Class 2
·General Hospital
SHAPE TO FIT COMPRESSION WEAR
FDA 510(k)
FDA Class 2
·General Hospital
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·June 7, 2013
PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 7, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
FDA Recall
Terminated
·Biogenex Laboratories·Product code NJT·September 5, 2006
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