8 results
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27ms
·
Sources: EU EUDAMED, US FDA
TSP Crosser Transseptal Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
MYRAY SKYVIEW
FDA 510(k)
FDA Class 2
·Dental
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GENDER SOLUTIONS PROLONG ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·July 22, 2011
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·June 20, 2013
PLUM A+3 PUMP MEDNET WIRELESS
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·September 29, 2008
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 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