11 results
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18ms
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Sources: EU EUDAMED, US FDA
ALLEN, ULTRA AND SMART SOCKETS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Performer Guiding Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
VERTETRAC
FDA 510(k)
FDA Class 1
·Orthopedic
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTL LTD·Product code BTR·January 22, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·January 27, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014
PERFORMER MULLINS GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 20, 2023
PERFORMER MULLINS GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 24, 2024
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 4, 2022
REMINGTON MEDICAL DISPOSABLE PACING CABLE
FDA Adverse Event
Malfunction
·REMINGTON MEDICAL·Product code DSA·September 13, 2002
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