9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Belvedere Lateral Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN
FDA 510(k)
FDA Class 2
·Microbiology
INFRARED EAR THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·January 14, 2019
PROTECTA XT DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 8, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KXA·May 20, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
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