15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Secret RF Smartcure Applicator with electrodes
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704513226·
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916120696·ZEUS®-L 55 x 23 x 18mm 28 Degree
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916120689·ZEUS®-L 55 x 23 x 18mm 14 Degree
ZIP'R MANTIS POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
VISIONSENSE STEREOSCOPIC VISION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 10, 2013
DBS LEAD
FDA Adverse Event
Malfunction
·MPROC, VILLALBA·Product code MHY·July 11, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 17, 2014
MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·October 24, 2019
MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·January 10, 2020
CPX4 PLUS SMOOTH TALL HEIGHT 550CC
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·April 19, 2022
CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·February 22, 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