12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI
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
LACTOSORB*
FDA UDI
BIOMET MICROFIXATION, INC·00841036056032·
LEONE SPA
FDA UDI
LEONE SPA·08033707014607·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 6
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197496049·RZ Rainer Ring Curettes
straig...
ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II
FDA 510(k)
FDA Class 2
·Cardiovascular
I-FUSE HAMMER TOE SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 7, 2011
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LWS·June 8, 2013
POLYFLUX R CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008
Allegiance Esmark 6' x 144' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Distributed by Cardinal Health, McGaw Park, IL 60085-8787, Made in Malaysia; Catalog 24593-064A
FDA Recall
Terminated
·International Medsurg Connection, Inc.·Product code MHW·August 16, 2006