10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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YO Home Sperm Test
FDA 510(k)
FDA Class 2
·Hematology
CVS Health
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428485941·Assorted Foam Antibacterial Bandages, assorted ...
CVS Health
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428498064·Wide Foam Antibacterial Bandages, all one size,...
CVS Health
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428412923·Wide Foam Antibacterial Bandages, all one size,...
AESKULISA DS DNA G
FDA 510(k)
FDA Class 2
·Immunology
Panda iRes Warmer, Giraffe Warmer
FDA 510(k)
FDA Class 2
·General Hospital
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·September 2, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 22, 2013
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