9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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71110 DESK CHARGER
FDA 510(k)
FDA Class 1
·Ophthalmic
Baha 5 SuperPower Earhook+ (Medium, Carbon)
FDA UDI
Cochlear Bone Anchored Solutions AB·09321502034494·
CAST BRWM, FRACTURE
FDA 510(k)
FDA Class 1
·Physical Medicine
Acclarix AX4 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM NT
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NKM·July 8, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 24, 2014
EMERGE¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·October 4, 2012
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 22, 2010
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