10 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Acetabular reamer ø70mm
FDA UDI
Incipio Devices SA·07630055301710·Acetabular reamer for hip arthroplasty
CANNULATED SCREW STERILE TRAY
FDA UDI
Biomet Orthopedics, LLC·00887868027338·
Tiger Shark System
FDA UDI
Choice Spine, LP·00840996166096·TIGER SHARK,STERILE,STR,9X24X16,12 DEG
KIMGUARD ONE-STEP STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ZENITH AAA ENDOVASCUALR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·November 21, 2008
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·September 2, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·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