12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRASCORE Focused Force PTA Balloon
FDA 510(k)
FDA Class 2
·Cardiovascular
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704511185·
XL EXTRACTION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LAG SCREW, STST 10.5X95MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 21, 2010
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·June 17, 2013
EON RECHARGEABLE IPG, 16-CHANNEL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 20, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 19, 2008
MALIBU
FDA Adverse Event
Injury
·SEASPINE INC.·Product code NKB·February 12, 2020
MALIBU
FDA Adverse Event
Injury
·SEASPINE INC.·Product code NKB·February 12, 2020
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·March 5, 2021
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