10 results
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18ms
·
Sources: EU EUDAMED, US FDA
AMERICAN DENTAL PRODUCTS ETCH-DETECT
FDA 510(k)
FDA Class 2
·Dental
C-PORT - HP POWER INJECTABLE PORT
FDA 510(k)
FDA Class 2
·General Hospital
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 8, 2006
MEDTRONIC SURGICAL TISSUE VALVE
FDA Adverse Event
Injury
·HEART VALVES SANTA ANA·Product code DYE·December 6, 2021
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 6, 2013
SECURA VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·August 8, 2014
LAMITRODE 44C SURGICAL LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 11, 2011
STERRAD 100NX STERILIZER 1-DR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 6, 2021
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