11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLY (VINYL) EXAM GLOVE, POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
NA
FDA UDI
KEY SURGICAL, INC.·10849771049569·K-Wires, Single trocar, Threaded, .062-inch (1....
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012962·K-Wires, Single trocar, Threaded, .062-inch (1....
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690191728·Revision Tibia Impactor Pad (Green)
O2Vent W
FDA 510(k)
FDA Class 2
·Dental
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
FDA 510(k)
FDA Class 2
·Microbiology
SPIROPERFECT
FDA Adverse Event
Malfunction
·MEDIKRO OY·Product code BZG·August 11, 2023
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 26, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 31, 2014
PUMP MMT-722NAP PRDGM INS V2.2 PL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code OYC·April 23, 2008
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