11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
WHOLEY HI-TORQUE GUIDE WIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
Symmetry Jameson Reynolds
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482127865·Symmetry® Scissors, Jameson Reynolds, Curved, S...
SYNTHES PANGEA SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MONOSPHERICAL SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
TI PANGEA LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code NKB·June 5, 2012
UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2M
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·November 14, 2012
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·October 4, 2010
AMS PERIGEE SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTP·June 5, 2014
TI PANGEA LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code NKB·June 5, 2012
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
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015