32 results
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40ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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eMurmur ID
FDA 510(k)
FDA Class 2
·Cardiovascular
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
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM LOT. 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2019
HEAL FORCE CO2 INCUBATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EASYSCAN MODEL 1.2
FDA 510(k)
FDA Class 2
·Ophthalmic
M.U.S.T. POLYAXIAL PEDICLE SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 10, 2025
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X30MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·May 14, 2024
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X35MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·March 10, 2021
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2023
M.U.S.T. RODS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·March 31, 2026
MYSPINE MC DRILL BASED GUIDE L05
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PQC·December 10, 2019
MECTALIF OBLIQUE (TI PEEK) TIPEEK 10X24X10 L5°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·June 25, 2024
ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·January 10, 2024
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·July 25, 2023
GLIDEPATH, 14.5F
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code MSD·June 17, 2013
SPACEMAKER BLUNT TIP TROCAR 12MM
FDA Adverse Event
Malfunction
·USSC PUERTO RICO·Product code GCJ·June 16, 2011
HEARTSTRING II PROXIMAL SEAL SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code DXC·September 22, 2008
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·May 22, 2020
MECTALIF POSTERIOR
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·October 8, 2025
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 26, 2019