12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Miracu
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776402457·Jacobson Micro Mosquito Fcps 5" Curved Extra De...
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361039·Integra® Miltex® Jacobson Micro Mosquito Forcep...
Lacrimal Probe
FDA UDI
KATENA PRODUCTS, INC.·00841668108819·SILICONE TUBING 12" (305MM) Long
Sentinel
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129322·PATHFINDER SL/SENTINEL 11 EVAL SYSTEM (ENG)
Pathfinder SL
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522125812·PATHFINDER SL/SENTINEL 11 EVAL SYSTEM (ENG)
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
S6 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·June 17, 2013
AMS SPHINCTER 800 URINARY PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code EZY·July 19, 2011
PROGRAMMING WAND
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 19, 2008
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