10 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIO-CLAD ALL POLY CUP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304255814·
14 WIRE STANDARD, 14 WIRE LS
FDA 510(k)
FDA Class 2
·Cardiovascular
POGS, MODEL 33C
FDA 510(k)
FDA Class 2
·Anesthesiology
MECTACER 01.29.207 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE XL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 3, 2022
MPACT FLAT PE HC LINER Ø32/F
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·June 25, 2018
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 10, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 11, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 15, 2011
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