11 results
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19ms
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Sources: EU EUDAMED, US FDA
CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981124496·16x14x7mm, 7 Degree, Interbody
Life Instruments
FDA UDI
Life Instrument Corporation·M930785090730·Micro Spatula Dissector Medium Bayonet Extended WL
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·00889981124499·Interbody, 16x14x7mm, 7 Degree, Sterile
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EQUINOXE CAGE GLENOID MEDIUM, ALPHA
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·August 26, 2024
SYMBIQ 3.13 DUAL CHA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 12, 2014
SYNREAM REAMER HEAD Ø18.5
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·November 29, 2012
ENDEAVOR RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·September 29, 2010
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