18 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vantage Titan 3T, MRT-3010/A7, M-Power GX
FDA 510(k)
FDA Class 2
·Radiology
PEDICLE SCREW MONOAXIAL SCREW 5X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 10, 2019
MODIFICATION TO: LOCATOR IMPLANT ANCHOR
FDA 510(k)
FDA Class 2
·Dental
HD-IVUS ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
THERAKOS CELLEX PHOTOPHERESIS SYETEM
FDA Adverse Event
Malfunction
·THERAKOS, INC.·Product code LNR·October 10, 2014
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 29, 2013
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 22, 2011
MUST PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2017
HAMMER
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·February 11, 2020
PEDICLE SCREW PEDICLE SCREW 7X45 (2 PCS)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·July 4, 2018
PUDENZ VALVE, 16MM, BURR HOLE, MEDIUM PRESSURE
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·June 20, 2018
PUDENZ VALVE, 16MM, BURR HOLE, MEDIUM PRESSURE
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·June 20, 2018
HAMMER
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·February 11, 2020
PUDENZ VALVE, 16MM, BURR HOLE, MEDIUM PRESSURE
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·June 20, 2018
LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Recall
Terminated
·Zest Anchors LLC·Product code DZE·January 16, 2014
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Enforcement
Class II
·Terminated·Zest Anchors LLC·February 12, 2014
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 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