9 results
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26ms
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Sources: EU EUDAMED, US FDA
X-RAY DIAGNOSTIC TABLE YSF-200-30-90
FDA 510(k)
FDA Class 2
·Radiology
TABLEPAD,FISHER,PFM
FDA UDI
ALIMED, INC.·00733657237245·
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110959·STERILIZING CASE SMALL
PVC Hydrophilic Urethral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RIVAL PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·October 29, 2010
ENDURITY SR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FNL·December 10, 2012
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