8 results
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18ms
·
Sources: EU EUDAMED, US FDA
GORE-TEX PERITONEAL CATHETERR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EC 2.7 ENDOSCOPIC CUTTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HDM99
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYMPHONY
FDA Adverse Event
Malfunction
·SORIN CRM·Product code NVZ·May 20, 2014
MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code KNW·October 30, 2007
CLEAN CARE CLEANING SOLUTION
FDA Adverse Event
Malfunction
·CIBA VISION·Product code LPN·October 31, 2012
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015
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