12 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS
FDA 510(k)
FDA Class 2
·Orthopedic
Jaeger
FDA UDI
Jaeger Medical GmbH·04250892900308·MasterScreen CPX
Jaeger
FDA UDI
Jaeger Medical GmbH·04250892902739·MasterScreen CPX
Jaeger
FDA UDI
Jaeger Medical GmbH·04250892905051·MasterScreen CPX
CENTRONAIL TITANIUM UNIVERSAL FEMORAL NAILING SYSTEM
FDA UDI
ORTHOFIX SRL·18032937163250·INSERTION KNOB
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100844·MCNEILL GLOBAL FIXATION RING SMALL
PRODIGY DIABETES MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ORTHOMESH
FDA 510(k)
FDA Class 2
·Orthopedic
DASH 3000, 4000 , 5000, REV 7.3
FDA Adverse Event
Malfunction
·GE HEALTHCARE, LLC·Product code MHX·October 13, 2014
CURLIN IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·May 30, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2011
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