10 results
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26ms
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Sources: EU EUDAMED, US FDA
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
FDA 510(k)
FDA Class 2
·Ophthalmic
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104400·Rod Straight 5.5 x 45mm
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970577·
UNITED UTF STEM
FDA 510(k)
FDA Class 2
·Orthopedic
CELSTAT
FDA 510(k)
FDA Unclassified
·Unknown
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013
PALMAZ GENESIS AMIIA
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·September 24, 2014
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON·Product code HET·June 3, 2011
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021
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