15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vathin Video Bronchoscope System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Reverse-Cyte 3% (A1, B)
FDA UDI
Medion Grifols Diagnostics AG·07640137340292·Reagent Red Blood Cells for confirmation of ABO...
ELMED
FDA UDI
ELMED INCORPORATED·00842180124479·5 MM DIA., 36 CM INSULATED L-HOOK TIP ELECTRODE...
Patient Monitoring Cables
FDA 510(k)
FDA Class 2
·Cardiovascular
TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)
FDA 510(k)
FDA Class 2
·Cardiovascular
SYRINGE 10ML SALINE XS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMF·September 16, 2020
BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·November 27, 2019
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 12, 2015
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 21, 2012
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·September 25, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
Phoenix AP AST Indicator Bag, Catalog Number 246006
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·March 6, 2019
BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·April 21, 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