12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Trak Plus Male Fertility Testing System
FDA 510(k)
FDA Class 2
·Hematology
X8 Locking Hex Driver
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057831·
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VISULAS TRION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2023
VANGUARD ROCC POR FEM S60 L
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·February 3, 2026
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 17, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 19, 2008
VANGUARD MONO FINNED STM TIB 71X8
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·August 9, 2023
VANGUARD ROCC POR FEM S60 L
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 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