12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INION FREEDOMPIN
FDA 510(k)
FDA Class 2
·Orthopedic
K133532
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·February 2, 2021
ZYGAFIX SPINAL FACET SCREW SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
FIREBIRD SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 22, 2026
SALTO TALARIS
FDA Adverse Event
Injury
·TORNIER SAS·Product code HSN·May 23, 2013
HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 20, 2011
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·June 2, 2025
VITEK® 2 AST-YS08 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code NGZ·January 11, 2018
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·September 11, 2025
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