10 results
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21ms
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Sources: EU EUDAMED, US FDA
Preview Digital Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NERVE MONITORING CABLE
FDA 510(k)
FDA Class 2
·Neurology
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PY2 PACING LEAD
FDA Adverse Event
Malfunction
·OSCOR INC.·Product code DTB·June 7, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 23, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQO·January 18, 2019
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2019
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2025
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